RPM June 2014, Vol 2, No 3

JUNE 2014

www.RheumatologyPracticeManagement.com

Data Management

Clinical Research and ICD-10: Tools for Success

By Allyson D. Eakin, RN, OCN, CCM, Clinical Research Coordinator, Arthritis & Osteoporosis Consultants of the Carolinas, Charlotte, NC

Volume 2 • Number 3

Nearly Half of Rheumatoid Arthritis Prescriptions Involve Copay Offset

By Kurt Ullman, RN, MHA, BSPA

Z

itter Health Insights (ZHI) re- rheumatologists, 100 patients who had cently released the latest edition used copay offset programs (COPs) for of its Co-Pay Offset Monitor, a their medications over the previous 6 publication that serves as a research months, and 25 specialty pharmacists. tool to help identify trends in copay The report shows that COPs have been assistance. The group surveyed 100 growing at aNURSE high rate.

FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND PRACTITIONERS Continued on page 17

From the Editor

Invitation to Serve “Mandatory staff meeting on ICD10, Thursday morning at 7,” the e-mail read.

Okay, I can zone out during this one; this won’t affect research. After all, the only International Classification of Diseases (ICD)-10 codes I need to know to write reports from the elecContinued on page 8

By Iris W. Nichols, President, National Organization of Rheumatology Managers; Editor-in-Chief, Rheumatology Practice Management

I

n just a few short months we will be in Louisville, KY, for our National Organization of Rheumatology Managers (NORM) conference, which is scheduled for September 12-13, 2014.

Members of the NORM Board of Directors and various committees have

spent innumerable hours throughout the year in planning and organizing the conference so it can meet our members’ expectations.

We all work hard between meetings as well as serving on various committees to ensure that NORM continues to Continued on page 10

In partnership with

Nat ion a l O r ga n iz at ion of o R he u m atolo g y Man a gers From the publishers of

© 2014 Engage Healthcare Communications, LLC

To manage selected adults with severe, active rheumatoid arthritis (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis, who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full-dose NSAIDs

greater methotrexate …made easy! *Compared with oral methotrexate.1 • Bioavailability of oral methotrexate plateaus at 15 mg. OtrexupTM (methotrexate) injection, for subcutaneous use, provides greater systemic exposure than oral methotrexate1 • Otrexup may provide benefits to patients experiencing an inadequate response to, or who cannot tolerate, methotrexate tablets1 • In a study of Otrexup, most patients found Otrexup easy to use and experienced minimal injection-related pain2 Indications • Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

Otrexup should not be used for the treatment of cancer.

Important Safety Information (ABBREVIATED) WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH • Serious toxic reactions and deaths have been reported with the use of methotrexate. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities.

• Methotrexate has been reported to cause fetal death and/or congenital anomalies, and is contraindicated in pregnancy.

• Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions.

• Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate along with some NSAIDs. • Hepatotoxicity, fibrosis and cirrhosis may occur after prolonged use.

• Methotrexate may cause interstitial pneumonitis at any time during therapy and has been reported at low doses. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.

• Diarrhea, ulcerative stomatitis, hemorrhagic enteritis and death from intestinal perforation may occur.

• Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur.

• Severe, occasionally fatal, skin reactions have been reported.

• Potentially fatal opportunistic infections may occur.

Contraindications • Pregnancy • Nursing mothers • Alcoholism or liver disease • Immunodeficiency syndromes • Preexisting blood dyscrasias • Hypersensitivity to methotrexate Warnings and Precautions: Organ system toxicity: Potential for serious toxicity. Only for use by physicians experienced in antimetabolite therapy.

Embryo-fetal toxicity: Exclude pregnancy before treatment. Avoid pregnancy if either partner is receiving Otrexup. Advise males to avoid pregnancy for at least 3 months after therapy and females to avoid pregnancy for at least 1 ovulatory cycle after therapy.

Effects on reproduction: May cause impairment of fertility, oligospermia and menstrual dysfunction.

Laboratory tests: Monitor complete blood counts, renal function and liver function tests.

Risks from improper dosing: Mistaken daily use has led to fatal toxicity Patients with impaired renal function, ascites, or pleural effusions: Elimination is reduced Dizziness and fatigue: May impair ability to drive or operate machinery.

Adverse Reactions Common adverse reactions are: nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, Otrexup.com dizziness, photosensitivity, and “burning of skin lesions.”

Please see adjacent pages for Brief Summary, including Boxed Warning.

References: 1. Otrexup [prescribing information]. Ewing, NJ: Antares Pharma Inc.; 2013. 2. Kivitz A, McLain D, Hill J, et al. Nearly pain-free self-administration of methotrexate using an investigational auto-injector: results from a phase 2 clinical trial in rheumatoid arthritis patients with mild-to-severe functional limitations. Poster presented at: American College of Rheumatology Annual Meeting; October 26-30, 2013; San Diego, California. Poster 1337.

© 2014 Antares Pharma Inc. 01/2014 OTX-64-13-12

*

OTREXUP™ (methotrexate) injection, for subcutaneous use.

Brief Summary of Prescribing Information WARNING: SEVERE TOXIC REACTIONS, INCLUDING EMBRYO-FETAL TOXICITY AND DEATH Otrexup should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Otrexup should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy.

Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities. Patients should be informed by their physician of the risks involved and be under a physician’s care throughout therapy [see Warnings and Precautions (5.1)].

1. Methotrexate has been reported to cause fetal death and/or congenital anomalies.

Therefore, Otrexup is not recommended for females of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks [see Warnings and Precautions (5.2)]. Otrexup is contraindicated in pregnant women [see Contraindications (4)].

2. Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of Otrexup administration [see Warnings and Precautions (5.6)].

3. Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and gastrointestinal toxicity have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs) [see Warnings and Precautions (5.1) and Drug Interactions (7.1)].

4. Methotrexate causes hepatotoxicity, fibrosis and cirrhosis, but generally only after prolonged use.

Acutely, liver enzyme elevations are frequently seen. These are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long-term treatment. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population [see Warnings and Precautions (5.1)].

5. Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation [see Warnings and Precautions (5.1)].

6. Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur [see Warnings and Precautions (5.1)].

7. Malignant lymphomas, which may regress following withdrawal of methotrexate, may occur in patients receiving low-dose methotrexate and, thus, may not require cytotoxic treatment. Discontinue Otrexup first and, if the lymphoma does not regress, appropriate treatment should be instituted [see Warnings and Precautions (5.8)].

8. Like other cytotoxic drugs, methotrexate may induce “tumor lysis syndrome” in patients with rapidly growing tumors [see Warnings and Precautions (5.9)].

9. Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of methotrexate. Reactions have occurred within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Recovery has been reported with discontinuation of therapy [see Warnings and Precautions (5.1)].

10. Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with methotrexate therapy [see Warnings and Precautions (5.1)].

11. Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis [see Warnings and Precautions (5.10)].

2 DOSAGE AND ADMINISTRATION 2.1 Important Dosing Information Otrexup is a single-dose auto-injector for once-weekly subcutaneous use only [see Warnings and Precautions (5.5)]. Administer Otrexup in the abdomen or the thigh. Otrexup is only available in doses between 10 to 25 mg in 5 mg increments. Use another formulation of methotrexate for alternative dosing in patients who require oral, intramuscular, intravenous, intra-arterial, or intrathecal dosing, doses less than 10 mg per week, doses more than 25 mg per week, high-dose regimens, or dose adjustments of less than 5 mg increments.

2.2 Rheumatoid Arthritis including Polyarticular Juvenile Idiopathic Arthritis Recommended starting dose of methotrexate: Adult RA: single oral doses of 7.5 mg weekly using an oral formulation of methotrexate. pJIA: 10 mg/m2 once weekly.

For patients switching from oral methotrexate to Otrexup, consider any differences in bioavailability between oral and subcutaneously administered methotrexate [see Clinical Pharmacology (12.3)].

Dosages may be adjusted gradually to achieve an optimal response. Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg/wk in adults. Although there is experience with doses up to 30 mg/m2/wk in children, there are too few published data to assess how doses over 20 mg/m2/wk might affect the risk of serious toxicity in children. Experience does suggest, however, that children receiving 20 to 30 mg/m2/wk (0.65 to 1.0 mg/kg/wk) may have better absorption and fewer gastrointestinal side effects if methotrexate is administered either intramuscularly or subcutaneously.

Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

The optimal duration of therapy is unknown. Limited data available from long-term studies in adults indicate that the initial clinical improvement is maintained for at least two years with continued therapy. When methotrexate is discontinued, the arthritis usually worsens within 3 to 6 weeks.

The patient should be fully informed of the risks involved and should be under constant supervision of the physician.

Assessment of hematologic, hepatic, renal, and pulmonary function should be made by history, physical examination, and laboratory tests before beginning, periodically during, and before reinstituting Otrexup therapy [see Warnings and Precautions (5.4)]. Females of childbearing potential should not be started on Otrexup until pregnancy is excluded [see Contraindications (4) and Warnings and Precautions (5.2)] All schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects.

Maximal myelosuppression usually occurs in seven to ten days.

2.3 Psoriasis Recommended starting dose of methotrexate: Psoriasis: single weekly oral, intramuscular, subcutaneous, or intravenous doses of 10-25 mg.

For patients switching from oral methotrexate to Otrexup, consider any differences in bioavailability between oral and subcutaneously administered methotrexate [see Clinical Pharmacology (12.3)].

Dosage may be gradually adjusted to achieve optimal clinical response; 30 mg/week should not ordinarily be exceeded. Once optimal clinical response has been achieved, the dosage should be reduced to the lowest possible amount of drug and to the longest possible rest period. The use of Otrexup may permit the return to conventional topical therapy, which should be encouraged.

2.4 Administration and Handling Otrexup is an auto-injector intended for subcutaneous use under the guidance and supervision of a physician.

Patients may self-inject with Otrexup if a physician determines that it is appropriate, if they have received proper training in how to prepare and administer the correct dose, and if they receive medical follow-up, as necessary.

A trainer device is available for training purposes.

Visually inspect Otrexup for particulate matter and discoloration prior to administration. Do not use Otrexup if the seal is broken.

Handle and dispose of Otrexup consistent with recommendations for handling and disposal of cytotoxic drugs1.

3 DOSAGE FORMS AND STRENGTHS Otrexup is an injection available as an autoinjector that administers a single 0.4 mL dose of methotrexate solution in the following dosage strengths:

• 10 mg/0.4 mL methotrexate

• 15 mg/0.4 mL methotrexate

• 20 mg/0.4 mL methotrexate

• 25 mg/0.4 mL methotrexate 4 CONTRAINDICATIONS Otrexup is contraindicated in the following: • Pregnancy Otrexup can cause fetal death or teratogenic effects when administered to a pregnant woman.

Otrexup is contraindicated in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [see Warnings and Precautions (5.2) and Use in Specific Populations (8.1)].

• Nursing Mothers Because of the potential for serious adverse reactions from methotrexate in breast fed infants, Otrexup is contraindicated in nursing mothers [see Use in Specific Populations (8.3)].

• Alcoholism or Liver Disease Patients with alcoholism, alcoholic liver disease or other chronic liver disease [see Warnings and Precautions (5.1)].

• Immunodeficiency Syndromes Patients who have overt or laboratory evidence of immunodeficiency syndromes [see Warnings and Precautions (5.1)].

• Preexisting Blood Dyscrasias Patients who have preexisting blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia, or significant anemia [see Warnings and Precautions (5.1)].

• Hypersensitivity Patients with a known hypersensitivity to methotrexate. Severe hypersensitivity reactions have been observed with methotrexate use [see Warnings and Precautions (5.1) and Adverse Reactions (6.1 and 6.2)].

5 WARNINGS AND PRECAUTIONS 5.1 Organ System Toxicity Otrexup should be used only by physicians whose knowledge and experience include the use of antimetabolite therapy. Because of the possibility of serious toxic reactions (which can be fatal), Otrexup should be used only in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy.

Deaths have been reported with the use of methotrexate in the treatment of malignancy, psoriasis, and rheumatoid arthritis. Patients should be closely monitored for bone marrow, liver, lung and kidney toxicities.

Otrexup has the potential for serious toxicity. Toxic effects may be related in frequency and severity to dose or frequency of administration but have been seen at all doses. Because they can occur at any time during therapy, it is necessary to follow patients on Otrexup closely. Most adverse reactions are reversible if detected early.

When such reactions do occur, the drug should be reduced in dosage or discontinued and appropriate corrective measures should be taken. If necessary, this could include the use of leucovorin calcium and/or acute, intermittent hemodialysis with a high-flux dialyzer [see Overdosage (10)]. If Otrexup therapy is reinstituted, it should be carried out with caution, with adequate consideration of further need for the drug and increased alertness as to possible recurrence of toxicity. The clinical pharmacology of methotrexate has not been well studied in older individuals.

Due to diminished hepatic and renal function as well as decreased folate stores in this population, relatively low doses should be considered, and these patients should be closely monitored for early signs of toxicity [see Use in Specific Populations (8.5)].

Gastrointestinal: Diarrhea and ulcerative stomatitis require interruption of therapy: otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.

If vomiting, diarrhea, or stomatitis occur, which may result in dehydration, Otrexup should be discontinued until recovery occurs. Otrexup should be used with extreme caution in the presence of peptic ulcer disease or ulcerative colitis.

Unexpectedly severe (sometimes fatal) gastrointestinal toxicity has been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.1)] Hematologic: Otrexup can suppress hematopoiesis and cause anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia, and/or thrombocytopenia. In patients with preexisting hematopoietic impairment, Otrexup should be used with caution, if at all. In controlled clinical trials conducted with another formulation of methotrexate in rheumatoid arthritis (n=128), leukopenia (WBC <3000/mm3) was seen in 2 patients, thrombocytopenia (platelets <100,000/mm3) in 6 patients, and pancytopenia in 2 patients.

Otrexup should be stopped immediately if there is a significant drop in blood counts. Patients with profound granulocytopenia and fever should be evaluated immediately and usually require parenteral broad-spectrum antibiotic therapy.

Unexpectedly severe (sometimes fatal) bone marrow suppression and aplastic anemia have been reported with concomitant administration of methotrexate (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs) [see Drug Interactions (7.1)].

Hepatic: Otrexup has the potential for acute (elevated transaminases) and chronic (fibrosis and cirrhosis) hepatotoxicity.

Chronic toxicity is potentially fatal; it generally has occurred after prolonged use (generally two years or more) and after a total dose of at least 1.5 grams. In studies in psoriatic patients, hepatotoxicity appeared to be a function of total cumulative dose and appeared to be enhanced by alcoholism, obesity, diabetes and advanced age. An accurate incidence rate has not been determined; the rate of progression and reversibility of lesions is not known.

Special caution is indicated in the presence of preexisting liver damage or impaired hepatic function.

In psoriasis, liver function tests, including serum albumin, should be performed periodically prior to dosing but are often normal in the face of developing fibrosis or cirrhosis. These lesions may be detectable only by biopsy.

The usual recommendation is to obtain a liver biopsy at 1) pretherapy or shortly after initiation of therapy (2 to 4 months), 2) a total cumulative dose of 1.5 grams, and 3) after each additional 1.0 to 1.5 grams. Moderate fibrosis or any cirrhosis normally leads to discontinuation of the drug; mild fibrosis normally suggests a repeat biopsy in 6 months.

Milder histologic findings such as fatty change and low grade portal inflammation, are relatively common pretherapy.

Although these mild changes are usually not a reason to avoid or discontinue Otrexup therapy, the drug should be used with caution.

In rheumatoid arthritis, age at first use of methotrexate and duration of therapy have been reported as risk factors for hepatotoxicity; other risk factors, similar to those observed in psoriasis, may be present in rheumatoid arthritis but have not been confirmed to date. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in this population. There is a combined reported experience in 217 rheumatoid arthritis patients with liver biopsies both before and during treatment (after a cumulative dose of at least 1.5 g) and in 714 patients with a biopsy only during treatment. There are 64 (7%) cases of fibrosis and 1 (0.1%) case of cirrhosis. Of the 64 cases of fibrosis, 60 were deemed mild. The reticulin stain is more sensitive for early fibrosis and its use may increase these figures. It is unknown whether even longer use will increase these risks.

Liver function tests should be performed at baseline at 4 to 8 week intervals in patients receiving Otrexup for rheumatoid arthritis. Pretreatment liver biopsy should be performed for patients with a history of excessive alcohol

consumption, persistently abnormal baseline liver function test values or chronic hepatitis B or C infection. During therapy, liver biopsy should be performed if there are persistent liver function test abnormalities or there is a decrease in serum albumin below the normal range (in the setting of well controlled rheumatoid arthritis).

If the results of a liver biopsy show mild changes (Roenigk, grades I, II, IIIa), Otrexup may be continued and the patient monitored as per recommendations listed above. Otrexup should be discontinued in any patient who displays persistently abnormal liver function tests and refuses liver biopsy or in any patient whose liver biopsy shows moderate to severe changes (Roenigk grade IIIb or IV).

Infection or Immunologic States: Otrexup should be used with extreme caution in the presence of active infection, and is contraindicated in patients with overt or laboratory evidence of immunodeficiency syndromes.

Immunization may be ineffective when given during Otrexup therapy. Immunization with live virus vaccines is generally not recommended. There have been reports of disseminated vaccinia infections after smallpox immunizations in patients receiving methotrexate therapy. Hypogammaglobulinemia has been reported rarely.

Potentially fatal opportunistic infections, especially Pneumocystis jiroveci pneumonia, may occur with Otrexup therapy. When a patient presents with pulmonary symptoms, the possibility of Pneumocystis jiroveci pneumonia should be considered.

Neurologic: There have been reports of leukoencephalopathy following intravenous administration of methotrexate to patients who have had craniospinal irradiation. Serious neurotoxicity, frequently manifested as generalized or focal seizures, has been reported with unexpectedly increased frequency among pediatric patients with acute lymphoblastic leukemia who were treated with intermediate-dose intravenous methotrexate (1 gm/m2). Symptomatic patients were commonly noted to have leukoencephalopathy and/or microangiopathic calcifications on diagnostic imaging studies. Chronic leukoencephalopathy has also been reported in patients who received repeated doses of high-dose methotrexate with leucovorin rescue even without cranial irradiation.

Discontinuation of methotrexate does not always result in complete recovery. A transient acute neurologic syndrome has been observed in patients treated with high dose regimens. Manifestations of this stroke-like encephalopathy may include confusion, hemiparesis, transient blindness, seizures and coma. The exact cause is unknown. After the intrathecal use of methotrexate, the central nervous system toxicity which may occur can be classified as follows: acute chemical arachnoiditis manifested by such symptoms as headache, back pain, nuchal rigidity, and fever; sub-acute myelopathy characterized by paraparesis/paraplegia associated with involvement with one or more spinal nerve roots; chronic leukoencephalopathy manifested by confusion, irritability, somnolence, ataxia, dementia, seizures and coma. This condition can be progressive and even fatal.

Pulmonary: Methotrexate-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported.

Pulmonary symptoms (especially a dry nonproductive cough) or a non-specific pneumonitis occurring during Otrexup therapy may be indicative of a potentially dangerous lesion and require interruption of treatment and careful investigation. Although clinically variable, the typical patient with methotrexate induced lung disease presents with fever, cough, dyspnea, hypoxemia, and an infiltrate on chest X-ray; infection (including pneumonia) needs to be excluded. This lesion can occur at all dosages.

Renal: Otrexup may cause renal damage that may lead to acute renal failure. High doses of methotrexate used in the treatment of osteosarcoma may cause renal damage leading to acute renal failure. Nephrotoxicity is due primarily to the precipitation of methotrexate and 7-hydroxymethotrexate in the renal tubules. Close attention to renal function including adequate hydration, urine alkalinization and measurement of serum methotrexate and creatinine levels are essential for safe administration.

Skin: Severe, occasionally fatal, dermatologic reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, exfoliative dermatitis, skin necrosis, and erythema multiforme, have been reported in children and adults, within days of oral, intramuscular, intravenous, or intrathecal methotrexate administration. Reactions were noted after single or multiple low, intermediate, or high doses of methotrexate in patients with neoplastic and non-neoplastic diseases.

Lesions of psoriasis may be aggravated by concomitant exposure to ultraviolet radiation.

Radiation dermatitis and sunburn may be “recalled” by the use of methotrexate.

Other precautions: Otrexup should be used with extreme caution in the presence of debility.

Methotrexate exits slowly from third space compartments (e.g., pleural effusions or ascites). This results in a prolonged terminal plasma half-life and unexpected toxicity. In patients with significant third space accumulations, it is advisable to evacuate the fluid before treatment and to monitor plasma methotrexate levels.

5.2 Embryo-Fetal Toxicity Methotrexate has been reported to cause fetal death and/or congenital anomalies. Therefore, Otrexup is not recommended for females of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Otrexup is contraindicated in pregnant women with psoriasis or rheumatoid arthritis.

Females of childbearing potential should not be started on Otrexup until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant while undergoing treatment. Appropriate steps should be taken to avoid conception during Otrexup therapy. Pregnancy should be avoided if either partner is receiving Otrexup; during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients.

5.3 Effects on Reproduction Methotrexate has been reported to cause impairment of fertility, oligospermia and menstrual dysfunction in humans, during and for a short period after cessation of therapy.

The risk of effects of reproduction should be discussed with both male and female patients taking Otrexup.

5.4 Laboratory Tests Patients undergoing Otrexup therapy should be closely monitored so that toxic effects are detected promptly. Baseline assessment should include a complete blood count with differential and platelet counts, hepatic enzymes, renal function tests and a chest X-ray.

During therapy, monitoring of these parameters is recommended: hematology at least monthly, renal function and liver function every 1 to 2 months [see Warnings and Precautions (5.1)].

During initial or changing doses, or during periods of increased risk of elevated methotrexate blood levels (e.g., dehydration), more frequent monitoring may also be indicated.

Liver Function Tests Transient liver function test abnormalities are observed frequently after methotrexate administration and are usually not cause for modification of methotrexate therapy. Persistent liver function test abnormalities, and/or depression of serum albumin may be indicators of serious liver toxicity and require evaluation [see Warnings and Precautions (5.1)].

A relationship between abnormal liver function tests and fibrosis or cirrhosis of the liver has not been established for patients with psoriasis. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population.

Pulmonary Function Tests Pulmonary function tests may be useful if methotrexate-induced lung disease is suspected, especially if baseline measurements are available [see Warnings and Precautions (5.1)].

5.5 Risks from Improper Dosing Both the physician and pharmacist should emphasize to the patient that Otrexup is administered weekly and that mistaken daily use has led to fatal toxicity [see Dosage and Administration (2)].

5.6 Patients with Impaired Renal Function, Ascites, or Pleural Effusions Methotrexate elimination is reduced in patients with impaired renal function, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity and require dose reduction or, in some cases, discontinuation of Otrexup administration.

5.7 Dizziness and Fatigue Adverse reactions, such as dizziness and fatigue, may affect the ability to drive or operate machinery.

5.8 Malignant Lymphomas Non-Hodgkin’s lymphoma and other tumors have been reported in patients receiving low-dose oral methotrexate.

However, there have been instances of malignant lymphoma arising during treatment with low-dose oral methotrexate, which have regressed completely following withdrawal of methotrexate, without requiring active anti-lymphoma treatment. Discontinue Otrexup first and, if the lymphoma does not regress, appropriate treatment should be instituted.

5.9 Tumor Lysis Syndrome Like other cytotoxic drugs, methotrexate may induce “tumor lysis syndrome” in patients with rapidly growing tumors.

5.10 Concomitant Radiation Therapy Methotrexate given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling.

• Organ System Toxicity [see Warnings and Precautions (5.1)]

• Embryo-Fetal Toxicity [see Warnings and Precautions (5.2)]

• Effects on Reproduction [see Warnings and Precautions (5.3)]

• Malignant Lymphomas [see Warnings and Precautions (5.8)] The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.

6.1 Clinical Trials Experience This section provides a summary of adverse reactions reported in subjects in clinical studies conducted with Otrexup as well as with methotrexate injection and oral methotrexate.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

Rheumatoid Arthritis The approximate incidences of methotrexate-attributed (i.e. placebo rate subtracted) adverse reactions in 12 to 18 week double-blind studies of patients (n=128) with rheumatoid arthritis treated with low-dose oral (7.5 to 15 mg/week) pulse methotrexate, are listed below. Virtually all of these patients were on concomitant nonsteroidal anti-inflammatory drugs and some were also taking low dosages of corticosteroids. Hepatic histology was not examined in these short-term studies.

Incidence greater than 10%: Elevated liver function tests 15%, nausea/vomiting 10%.

Incidence 3% to 10%: Stomatitis, thrombocytopenia (platelet count less than 100,000/mm3).

Incidence 1% to 3%: Rash/pruritis/dermatitis, diarrhea, alopecia, leukopenia (WBC less than 3000/mm3), pancytopenia, dizziness.

Two other controlled trials of patients (n=680) with Rheumatoid Arthritis on 7.5 mg to 15 mg/wk oral doses showed an incidence of interstitial pneumonitis of 1%.

Other less common reactions included decreased hematocrit, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, and vaginal discharge.

Polyarticular Juvenile Idiopathic Arthritis The approximate incidences of adverse reactions reported in pediatric patients with pJIA treated with oral, weekly doses of methotrexate (5 to 20 mg/m2/wk or 0.1 to 0.65 mg/kg/wk) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m2/wk in pJIA, the published data for doses above 20 mg/m2/wk are too limited to provide reliable estimates of adverse reaction rates.

Psoriasis There are two literature reports (Roenigk, 1969, and Nyfors, 1978) describing large series (n=204, 248) of psoriasis patients treated with methotrexate. Dosages ranged up to 25 mg per week and treatment was administered for up to four years. With the exception of alopecia, photosensitivity, and “burning of skin lesions” (each 3% to 10%), the adverse reaction rates in these reports were very similar to those in the rheumatoid arthritis studies. Rarely, painful plaque erosions may appear (Pearce, HP and Wilson, BB: J Am Acad Dermatol 35: 835-838, 1996).

6.2 Other Adverse Reactions Other adverse reactions that have been reported with methotrexate in oncology, RA, pJIA, and psoriasis patients are listed below by organ system.

Alimentary System: gingivitis, pharyngitis, stomatitis, anorexia, nausea, vomiting, diarrhea, hematemesis, melena, gastrointestinal ulceration and bleeding, enteritis, pancreatitis.

Blood and Lymphatic System Disorders: suppressed hematopoiesis, anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, eosinophilia, lymphadenopathy and lymphoproliferative disorders (including reversible). Hypogammaglobulinemia has been reported rarely.

Cardiovascular: pericarditis, pericardial effusion, hypotension, and thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus).

Central Nervous System: headaches, drowsiness, blurred vision, transient blindness, speech impairment including dysarthria and aphasia, hemiparesis, paresis and convulsions have also occurred following administration of methotrexate. Following low doses, there have been occasional reports of transient subtle cognitive dysfunction, mood alteration or unusual cranial sensations, leukoencephalopathy, or encephalopathy.

Hepatobiliary Disorders: hepatotoxicity, acute hepatitis, chronic fibrosis and cirrhosis, hepatic failure, decrease in serum albumin, liver enzyme elevations.

Infection: There have been case reports of sometimes fatal opportunistic infections in patients receiving methotrexate therapy for neoplastic and non-neoplastic diseases. Pneumocystis jiroveci pneumonia was the most common opportunistic infection. There have also been reports of infections, pneumonia, Cytomegalovirus infection, including cytomegaloviral pneumonia, sepsis, fatal sepsis, nocardiosis; histoplasmosis, cryptococcosis, Herpes zoster, Herpes simplex hepatitis, and disseminated Herpes simplex.

Musculoskeletal System: stress fracture.

Ophthalmic: conjunctivitis, serious visual changes of unknown etiology.

Pulmonary System: respiratory fibrosis, respiratory failure, alveolitis, interstitial pneumonitis deaths have been reported, and chronic interstitial obstructive pulmonary disease has occasionally occurred.

Skin: erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin necrosis, skin ulceration and exfoliative dermatitis.

Urogenital System: severe nephropathy or renal failure, azotemia, cystitis, hematuria, proteinuria; defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, vaginal discharge, and gynecomastia; infertility, abortion, fetal death, fetal defects.

Other rarer reactions related to or attributed to the use of methotrexate such as nodulosis, vasculitis, arthralgia/myalgia, loss of libido/ impotence, diabetes, osteoporosis, sudden death, lymphoma, including reversible lymphomas, tumor lysis syndrome, soft tissue necrosis and osteonecrosis. Anaphylactoid reactions have been reported.

7 DRUG INTERACTIONS 7.1 Aspirin, Nonsteroidal Anti-Inflammatory Drugs, and Steroids Nonsteroidal anti-inflammatory drugs (NSAIDs) should not be administered prior to or concomitantly with the high doses of methotrexate, such as used in the treatment of osteosarcoma. Concomitant administration of some NSAIDs with high dose methotrexate therapy has been reported to elevate and prolong serum methotrexate levels, resulting in deaths from severe hematologic and gastrointestinal toxicity [see Warnings and Precautions (5.1)].

Caution should be used when NSAIDs and salicylates are administered concomitantly with lower doses of methotrexate, including Otrexup. These drugs have been reported to reduce the tubular secretion of methotrexate in an animal model and may enhance its toxicity.

Despite the potential interactions, studies of methotrexate in patients with rheumatoid arthritis have usually included concurrent use of constant dosage regimens of NSAIDs, without apparent problems. It should be appreciated, however, that the doses used in rheumatoid arthritis (7.5 to 15 mg/week) are somewhat lower than those used in psoriasis and that larger doses could lead to unexpected toxicity. Aspirin, NSAIDs, and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylates has not been fully explored. Steroids may be reduced gradually in patients who respond to methotrexate.

7.2 Proton Pump Inhibitors (PPIs) Use caution if high-dose methotrexate is administered to patients receiving proton pump inhibitor (PPI) therapy.

Case reports and published population pharmacokinetic studies suggest that concomitant use of some PPIs, such as omeprazole, esomeprazole, and pantoprazole, with methotrexate (primarily at high dose), may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. In two of these cases, delayed methotrexate elimination was observed when high-dose methotrexate was co-administered with PPIs, but was not observed when methotrexate was co-administered with ranitidine. However, no formal drug interaction studies of methotrexate with ranitidine have been conducted.

7.3 Oral Antibiotics Oral antibiotics such as tetracycline, chloramphenicol, and nonabsorbable broad spectrum antibiotics, may decrease intestinal absorption of methotrexate or interfere with the enterohepatic circulation by inhibiting bowel flora and suppressing metabolism of the drug by bacteria.

Penicillins may reduce the renal clearance of methotrexate; increased serum concentrations of methotrexate with concomitant hematologic and gastrointestinal toxicity have been observed with high and low dose methotrexate.

Use of Otrexup with penicillins should be carefully monitored.

Trimethoprim/sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate effect.

7.4 Hepatotoxins The potential for increased hepatotoxicity when methotrexate is administered with other hepatotoxic agents has not been evaluated. However, hepatotoxicity has been reported in such cases. Therefore, patients receiving concomitant therapy with Otrexup and other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine) should be closely monitored for possible increased risk of hepatotoxicity.

7.5 Theophylline Methotrexate may decrease the clearance of theophylline; theophylline levels should be monitored when used concurrently with Otrexup.

7.6 Folic Acid and Antifolates Vitamin preparations containing folic acid or its derivatives may decrease responses to systemically administered methotrexate. Preliminary animal and human studies have shown that small quantities of intravenously administered leucovorin enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin may reduce the efficacy of intrathecally administered methotrexate. Folate deficiency states may increase methotrexate toxicity.

Trimethoprim/sulfamethoxazole has been reported rarely to increase bone marrow suppression in patients receiving methotrexate, probably by decreased tubular secretion and/or an additive antifolate effect.

7.7 Mercaptopurine Methotrexate increases the plasma levels of mercaptopurine. The combination of Otrexup and mercaptopurine may therefore require dose adjustment.

7.8 Other Drugs Methotrexate is partially bound to serum albumin, and toxicity may be increased because of displacement by certain drugs, such as salicylates, phenylbutazone, phenytoin, and sulfonamides.

Renal tubular transport is also diminished by probenecid; use of Otrexup with this drug should be carefully monitored.

Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine, or cytotoxic agents, has not been studied and may increase the incidence of adverse effects.

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category X [see Contraindications (4)] Methotrexate has been reported to cause embryotoxicity, fetal death, congenital anomalies, and abortion in humans and is contraindicated in pregnant women.

8.3 Nursing Mothers Because of the potential for serious adverse reactions from methotrexate in breast fed infants, methotrexate is contraindicated in nursing mothers. Therefore, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Methotrexate has been detected in human breast milk. The highest breast milk to plasma concentration ratio reached was 0.08:1.

8.4 Pediatric Use The safety and effectiveness of methotrexate, including Otrexup, have not been established in pediatric patients with psoriasis.

The safety and effectiveness of Otrexup have not been established in pediatric patients with neoplastic diseases.

The safety and effectiveness of methotrexate have been established in pediatric patients with polyarticular juvenile idiopathic arthritis [see Clinical Studies (14.2)].

Published clinical studies evaluating the use of methotrexate in children and adolescents (i.e., patients 2 to 16 years of age) with pJIA demonstrated safety comparable to that observed in adults with rheumatoid arthritis [see Adverse Reactions (6.1)].

Otrexup does not contain a preservative. However, methotrexate injectable formulations containing the preservative benzyl alcohol are not recommended for use in neonates. There have been reports of fatal ‘gasping syndrome’ in neonates (children less than one month of age) following the administrations of intravenous solutions containing the preservative benzyl alcohol. Symptoms include a striking onset of gasping respiration, hypotension, bradycardia, and cardiovascular collapse.

Serious neurotoxicity, frequently manifested as generalized or focal seizures, has been reported with unexpectedly increased frequency among pediatric patients with acute lymphoblastic leukemia who were treated with intermediate-dose intravenous methotrexate (1 gm/m2) [see Warnings and Precautions (5.1)].

8.5 Geriatric Use Clinical studies of methotrexate did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious reflecting the greater frequency of decreased hepatic and renal function, decreased folate stores, concomitant disease or other drug therapy (i.e., that interfere with renal function, methotrexate or folate metabolism) in this population [see Warnings and Precautions (5.1) Drug Interactions (7.7) and Use in Specific Populations (8.7)]. Since decline in renal function may be associated with increases in adverse reactions and serum creatinine measurements may over estimate renal function in the elderly, more accurate methods (i.e., creatinine clearance) should be considered. Serum methotrexate levels may also be helpful. Elderly patients should be closely monitored for early signs of hepatic, bone marrow and renal toxicity. In chronic use situations, certain toxicities may be reduced by folate supplementation. Post-marketing experience suggests that the occurrence of bone marrow suppression, thrombocytopenia, and pneumonitis may increase with age [see Warnings and Precautions (5.1)].

8.6 Females and Males of Reproductive Potential Otrexup is not recommended for females of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the considered risks. Females of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counseled on the serious risk to the fetus should they become pregnant while undergoing treatment [see Use in Specific Populations (8.1)].

Appropriate steps should be taken to avoid conception during Otrexup therapy. Pregnancy should be avoided if either partner is receiving methotrexate; during and for a minimum of three months after therapy for male patients, and during and for at least one ovulatory cycle after therapy for female patients.

Methotrexate has been reported to cause impairment of fertility, oligospermia and menstrual dysfunction in humans, during and for a short period after cessation of therapy.

8.7 Renal Impairment Methotrexate elimination is reduced in patients with impaired renal function. Such patients require especially careful monitoring for toxicity and require dose reduction or, in some cases, discontinuation of Otrexup administration.

8.8 Hepatic Impairment The effect of hepatic impairment on methotrexate pharmacokinetics has not been studied. Otrexup is contraindicated in patients with alcoholic liver disease or other chronic liver disease. Patients with obesity, diabetes, hepatic fibrosis or steatohepatitis are at increased risk for hepatic injury and fibrosis secondary to methotrexate, and should be monitored closely [see Warnings and Precautions (5.1)].

10 OVERDOSAGE Leucovorin is indicated to diminish the toxicity and counteract the effect of inadvertently administered overdosages of methotrexate. Leucovorin administration should begin as promptly as possible. As the time interval between methotrexate administration and leucovorin initiation increases, the effectiveness of leucovorin in counteracting toxicity decreases. Monitoring of the serum methotrexate concentration is essential in determining the optimal dose and duration of treatment with leucovorin.

In cases of massive overdosage, hydration and urinary alkalinization may be necessary to prevent the precipitation of methotrexate and/or its metabolites in the renal tubules. Generally speaking, neither hemodialysis nor peritoneal dialysis has been shown to improve methotrexate elimination. However, effective clearance of methotrexate has been reported with acute, intermittent hemodialysis using a high-flux dialyzer (Wall, SM et al: Am J Kidney Dis 28 (6): 846-854, 1996).

Accidental intrathecal overdosage may require intensive systemic support, high-dose systemic leucovorin, alkaline diuresis and rapid CSF drainage and ventriculolumbar perfusion.

In postmarketing experience, overdose with methotrexate has generally occurred with oral and intrathecal administration, although intravenous and intramuscular overdose have also been reported.

Reports of oral overdose often indicate accidental daily administration instead of weekly (single or divided doses).

Symptoms commonly reported following oral overdose include those symptoms and signs reported at pharmacologic doses, particularly hematologic and gastrointestinal reaction. For example, leukopenia, thrombocytopenia, anemia, pancytopenia, bone marrow suppression, mucositis, stomatitis, oral ulceration, nausea, vomiting, gastrointestinal ulceration, gastrointestinal bleeding. In some cases, no symptoms were reported.

There have been reports of death following overdose. In these cases, events such as sepsis or septic shock, renal failure, and aplastic anemia were also reported.

Symptoms of intrathecal overdose are generally central nervous system (CNS) symptoms, including headache, nausea and vomiting, seizure or convulsion, and acute toxic encephalopathy. In some cases, no symptoms were reported. There have been reports of death following intrathecal overdose. In these cases, cerebellar herniation associated with increased intracranial pressure, and acute toxic encephalopathy have also been reported.

There are published case reports of intravenous and intrathecal carboxypeptidase G2 treatment to hasten clearance of methotrexate in cases of overdose.

13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Methotrexate has been evaluated in a number of animal studies for carcinogenic potential with inconclusive results.

Although there is evidence that methotrexate causes chromosomal damage to animal somatic cells and human bone marrow cells, the clinical significance remains uncertain.

Data are available regarding the risks for pregnancy and for fertility in humans [see Use in Specific Populations (8.1 and 8.6)].

15 REFERENCES 1. “Hazardous Drugs”. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html 16 HOW SUPPLIED/STORAGE AND HANDLING Otrexup contains methotrexate in a preservative-free sterile solution for a single subcutaneous injection. Otrexup is available in the following strengths and configurations.

Otrexup (methotrexate) injection 10 mg/0.4 mL

• Carton of 1 NDC 54436-010-01

• Carton of 4 NDC 54436-010-04

• Otrexup NDC 54436-010-02 Otrexup (methotrexate) injection 15 mg/0.4 mL

• Carton of 1 NDC 54436-015-01

• Carton of 4 NDC 54436-015-04

• Otrexup NDC 54436-015-02 Otrexup (methotrexate) injection 20 mg/0.4 mL

• Carton of 1 NDC 54436-020-01

• Carton of 4 NDC 54436-020-04

• Otrexup NDC 54436-020-02 Otrexup (methotrexate) injection 25 mg/0.4 mL

• Carton of 1 NDC 54436-025-01

• Carton of 4 NDC 54436-025-04

• Otrexup NDC 54436-025-02 Store at controlled room temperature, 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).

PROTECT FROM LIGHT. Handling and Disposal Handle and dispose of Otrexup consistent with recommendations for handling and disposal of cytotoxic drugs.1 Address Medical Inquiries to: Antares Pharma, Inc. Medical Communications 100 Princeton South, Suite 300 Ewing, NJ 08628 1-855-Otrexup (1-855-687-3987) Manufactured for: Antares Pharma, Inc. 100 Princeton South, Suite 300 Ewing, NJ 08628 USA Otrexup™ is subject of US Patent Nos. 7,776,015, 8,021,335, 6,746,429, 7,744,582 and 8,480,631. ©2013 Antares Pharma, Inc., Ewing, NJ 08628

In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne M. Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton

JUNE 2014

www.RheumatologyPracticeManagement.com

Volume 2 • Number 3

Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Melissa Lawlor The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede

Data Management

Clinical Research and ICD-10: Tools for Success................................. 1

By Allyson D. Eakin, RN, OCN, CCM

From the Editor

Invitation to Serve........................................................................................ 1

FOR ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS By IrisOFFICE W. Nichols

Copay Assistance

Nearly Half of Rheumatoid Arthritis Prescriptions Involve Copay Offset................................................................................................. 1

By Kurt Ullman, RN, MHA, BSPA

Patients Tap into Copay Offset Programs........................................... 18

By Kurt Ullman, RN, MHA, BSPA

Director, Creative & Design Robyn Jacobs

Continued on page 7

Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Manager Jini Gopalaswamy Project Coordinators Deanna Martinez Jackie Luma IT Specialist Carlton Hurdle Executive Administrator Rachael Baranoski Administrative Coordinator Stephanie Ramadan Office Coordinator Robert Sorensen Engage Healthcare Communications, LLC 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

BPA Worldwide membership applied for January 2014.

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Mission Statement Rheumatology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care patients deserve, providers must master the ever-changing business of rheumatology. Rheumatology Practice Management offers process solutions for members of the rheumatology care team—physicians, nurses, and auxilliary clinical staff, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

Rheumatology Practice Management™, ISSN 2164-4403 (print), is published 6 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512.

Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Rheumatology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Rheumatology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Rheumatology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Rheumatology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

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In This Issue

Continued from page 6

Wealth Management

Investing: Where to Put Your Money Now........................................................................................... 19

By W. Ben Utley, CFP®, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Physician-Hospital Alignment Series

Do’s and Don’ts in Physician-Hospital Alignment, Part 1................................................................... 21

By Max Reiboldt, CPA

FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS

Drug Update

Otrexup (Methotrexate) Injection: Novel Methotrexate Delivery System for Patients with Rheumatoid Arthritis..................................................................................... 24

By Lisa A. Raedler, PhD, RPh

The ACA Exchanges

MGMA Survey Reveals Drawbacks to Participation in ACA Insurance Exchange Program Networks............................................................................................................... 32

By Rosemary Frei, MSc

Best Practices

Bone Mineral Density Should Be Checked in All Hypogonadal Men.............................................. 34

By Rosemary Frei, MSc

Editorial Advisory Board Editor-in-Chief Iris W. Nichols

President National Organization of Rheumatology Managers Wilmington, NC Practice Administrator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Ana Reyes-Cartagena

Director of Clinical Practice Arthritis & Rheumatism Associates, P.C. Wheaton, MD

Practice Administrator Premier HealthCare Associates, Inc Richmond, VA

Allyson D. Eakin, RN, OCN, CCM

Clinical Research Coordinator Arthritis & Osteoporosis Consultants of the Carolinas Charlotte, NC

Nancy Ellis

Kyle Harner, MD

Helen Hinkle

Linda McKee

Mark Post

Jay Salliotte

Practice Administrator Piedmont Arthritis Clinic Greenville, SC

Practice Administrator Rheumatic Disease Associates Ltd Willow Grove, PA

Marjorie Collings

Carolina Arthritis Center Greenville, NC

Administrator North Texas Joint Care, P.A. Dallas, TX

June 2014

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Office Administrator Rheumatology Associates of South Texas San Antonio, TX

Business Manager Advanced Rheumatology Lansing, MI

www.RheumatologyPracticeManagement.com

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Data Management

Clinical Research and ICD-10...Continued from the cover tronic health records (EHRs) are the ones for rheumatoid arthritis, osteoarthritis, psoriatic arthritic, systemic lupus erythematosus, osteoporosis, and gout, and I already know those.

What a snooze-fest!

And then the presentation started.

Any potential research site that has ever had to complete a feasibility survey for a potential new research study knows the kinds of questions you must answer: basic information on the site, previous research study experience, logistics, equipment, staffing, etc. And then they ask for numbers: How many potential subjects with this particular diagnosis do you have in your database? How many have had this disease-modifying antirheumatic drug (DMARD) or that biologic, and for how long?

How many are seropositive? How many will meet the tender/swollen joint count inclusion criteria? How many have other overlapping or exclusionary comorbidities? Based upon these answers, how many potential subjects do you think you can enroll in this study?

The list can be exhaustive based upon the protocol’s inclusion and exclusion criteria. The task of data mining your patient database can be even more daunting. In the world of paper charts, this can take many person-hours of reading old office notes and requires an enormous amount of digging through charts for historic serology, past medications used, and documentation of the presence or absence of comorbidities. Many of us will confer with physician investigators and give it our best estimate.

While the advent of EHRs has given us a tool to improve our ability to data mine for participants, we can still end up giving a best guess. Sure, you can write a report that will give you the number of patients with a

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diagnosis of rheumatoid arthritis. If your EHR is robust, if specific data have been abstracted from the paper chart, and if it can be entered into the EHR as a discreet data point, you can build a report query to determine the number of patients with a specific diagnosis who are receiving specific medications but

Allyson D. Eakin

The task of data mining your patient database can be...daunting.

not other exclusionary medications.

But joints involved? Seropositivity?

Exclusionary comorbidities? These can be trickier when you are trying to extract data that more closely match a protocol’s inclusion and exclusion criteria. This is the information that can truly help determine whether a particular study is a good match for your patient base, and it can also be the most elusive to easily extract from your EHR. Enter ICD-10.

Most know that the ICD-9 code for rheumatoid arthritis is 714.0.

Starting on October 1, 2015, though, the ICD-10 code will follow a different structure and will begin by

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indicating the category (according to body system or nature of injury or disease). Not only will the code number change, but there will also be defined logical structure to the code, as follows: To the left of the decimal point: • Digits 1 to 3 will refer to the category • Digit 1 is always alphabetic • Digits 2 to 3 can be alpha or numeric.

Therefore rheumatoid arthritis with rheumatoid factor (RF) will now be M05. Rheumatoid arthritis without RF factor will be M06.

What comes to the right of the decimal point, digits 4 to 7, can hold the pot of gold for a research department looking to extract better, more meaningful data from its EHR. • Digits 4 to 6 will cover clinical details such as severity, etiology, and anatomic site (among others), and are either alphabetic or numeric • Digit 7 will serve as an extension when necessary, and will be either alphabetic or numeric.

For example, rheumatoid arthritis with RF factor with affected joints on the right hand will be M05.741.

If the left hand is also affected, there will be an additional code of M05.742. The same logic holds true for the right ankle/foot and the left ankle/foot (ICD-10 codes M05.771 and M05.772, respectively). If a patient is RF-positive and has Felty syndrome, which is a common exclusion criteria in research protocols, the code will be M05.0.

Additional comorbidities and drug codes can also easily be included into the report query.

Instead of creating a report for all rheumatoid arthritis patients, adding in the drug codes for a specific DMARD and/or specific biologic, and then having to pull the chart and read through all the office visits for

Data Management

joint involvement and historic laboratory values for seropositivity as well as exclusionary comorbidities, with ICD-10 you may be able to come close to the holy grail: a report that more closely matches the inclusion and exclusion criteria for your potential study. And these data can greatly reduce the person-hour intensiveness of searching through your patient database. Now the feasibility questionnaire can become a meaningful tool to help determine whether this is a study for which you can fulfill the enrollment criteria. We’ve all been stuck managing a study for which our best guess was not quite good

While the advent of EHRs has given us a tool to improve our ability to data mine for participants, we can still end up giving a best guess.

enough. The time it takes to manage a study that is not generating revenue is enormous. And we all know that

time equals resources spent, not revenue generated.

Immerse yourself in the system.

You may not use it on a daily basis, but learn the codes that can specifically impact clinical research.

Become involved on the front end, and be a resource on how data specific to your research patients are abstracted from a paper chart to the EHR. In today’s healthcare climate we must incorporate new tools available in order to work smarter. Think about the type of data you need, and learn how ICD10 can help you extract that data from your EHRs. l

CALL FOR SUBMISSIONS

?

Do you have a practice management solution to share In your background as a rheumatology practice manager, it’s likely there’s one business experience— and maybe more—that practice managers across the nation would want to read about.

High-interest topics include: the solution you found to a practice management challenge, reimbursement, your experience with EMR, Medicare audits, a memorable encounter that shaped the way you now run your business and/or practice medicine, or how you successfully integrated ancillary products and services into your practice as a revenue generator.

FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, AND NURSE PRACTITIONERS

a 1000- to 2000-word original article, previously unpublished Send us your ideas! Submit and submitted exclusively to Rheumatology Practice Management, that your fellow practice managers will want to read.

E-Mail to: acooper@the-lynx-group.com

RPM1/2pg_61014

June 2014

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www.RheumatologyPracticeManagement.com

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From the Editor

Invitation to Serve Continued from the cover grow and become stronger. Part of the growth and development of NORM is having an active and involved board, and each year at our conference we hold elections to fill board positions. This year we have 3 members who will rotate off the board.

We have developed an Education Committee that has worked hard to develop education modules, which are close to being rolled out. Our current website does not have the capability to host these modules; otherwise, you would have these modules in your hands at this time.

This is just one of the many unique challenges we face as your Board of Directors.

In order to be a board member you must be a manager or administrator of a rheumatology practice and a current member of NORM. Our practices require full-time focus and devotion to the day-to-day operations. We all work hard juggling daily challenges and priorities.

As I have said before, you would not be a member of NORM if you did not have the drive, a high level of expectations, and a desire to learn, network, and make our specialty stronger. By the same token, with our practices being so busy, it is difficult for us to be away from the office. Therefore, it is important to be aware of the duties involved in serving on the NORM board.

The current board would like to take this opportunity and use this platform to explain the time commitment necessary for this position.

In addition to a monthly teleconference call (at least 1 hour long), duties include the following: Three “fly-in” board meetings: The NORM conference and other business are discussed and group decisions are made at these meetings.

We have found that as the organization grows, person-to-person meet-

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ings have allowed us to accomplish many things. With travel, this could be as many as 8 to 12 days throughout the year, some of which are weekends.

The initial fly-in meeting usually takes place in October so conference details can be discussed and we can begin our preparation for next year’s conference. We have been fortunate that these fly-in meetings have been supported by some of our corporate members. In return for their support, we meet with them and have some incredibly good brainstorming sessions.

National conference: The NORM conference is 7 days (Monday to Sunday). Prior to the conference, we meet with our corporate members, a provision required by our bylaws. We attend the conference Thursday to Saturday afternoon, and then after the conference concludes, we meet Saturday afternoon to elect officers for the upcoming year and do a preliminary conference wrap-up.

Committee assignments: These committees develop goals and services for membership. Our current active committees are Policy and Procedure, Charity, Education, Finance, Legislative, Membership, Nominating, Group Purchasing Organization, and Conference. Each board member serves on specific committees since reports must be given back to the entire NORM board.

Serving on the NORM board has been one of the most rewarding experiences I have had. It has given me the opportunity to meet and work with so many wonderful people who share the same passion as I do when it comes to our specialty. We are able to work with our business partners in developing webinars, in-office presentations, a new website, and new publications.

This article is addressed to mem-

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bers who want to be involved and who would be interested in joining the board. To continue to grow and focus our organization, we want to have an involved membership. That involvement includes members taking on responsibilities that ensure the continued running of this dynamic entity. You will have an opportunity to serve with others who are interested in growing our specialty. You will have an opportunity to be involved at a local, state, regional, and even national level. Please consider the opportunity.

I am very proud of the current board and have the utmost respect for past board members. I am grateful for the Coalition of State Rheumatology Organizations (CSRO) for thinking it was important that not only the physicians become more involved in their specialty but the managers as well. “This organization is a group of state or regional professional rheumatology societies formed in order to advocate for excellence in rheumatologic disease care and to ensure access to the highest quality care for the management of rheumatologic and musculoskeletal diseases,” the CSRO notes on its site. NORM was formed due to its vision.

If you are interested in being considered for the Board of Directors, please take a moment and e-mail your interest to our current nominating committee, which comprises Dave Rothhaas (past president) at dave@dmandelmd.com or Karen Grace (current board member and co-chair) at kgrace@arthritisclinic. org. Please provide either a short bio or resume for presentation to the current Board of Directors, and to the membership thereafter.

I appreciate your consideration and look forward to seeing all of you at the conference in September. l

Copay Assistance

Nearly Half of Rheumatoid Arthritis Prescriptions…Continued from the cover “The point of the survey was to get a sense of what impacts co-pay offset programs were having on doctor’s prescribing behavior,” said Melinda C. Haren, RN, senior director of access strategies at Zitter. “We also were looking at whether the patients found one kind of program easier to use than others.”

ZHI’s most recent publication has shown that there are 561 offset programs being run for more than 700 brand-name drugs. This is an increase of 34% across all therapeutic classes since the original survey was published in 2013. Only 12% of the copay programs were for products with an AB-rated generic equivalent.

Half of RA Prescriptions Offset More than 1 of every 3 specialty pharmaceutical prescriptions were paid for using a copay program.

There was a great deal of variation among specialty medication categories. However, more than half of rheumatoid arthritis (RA) medications were offset, the highest among the specialty areas. This is in stark contrast to oral oncology medicines, where there was some kind of assistance for only 7% of prescriptions.

In the sample reviewed by Zitter, RA accounted for about half of specialty pharmacy scripts. The average copay prior to any offset was $60; this often was reduced to $5 or less

following the payment assistance.

“Specialty medications are highly utilized, and there are dynamics that are different from one to another,” noted Ms Haren. “You would instinctively think that oncology has to be the group where COPs are used most often, but that isn’t the case. RA biologics have much more use of these programs than other specialty therapies.”

More than half of rheumatoid arthritis medications were offset, the highest among the specialty areas. This is in stark contrast to oral oncology medicines, where there was some kind of assistance for only 7% of prescriptions.

Differences Between Medications This may be related to a number of factors, Ms Haren said. Most cancer therapies do not have direct competitors, so payers often cover them with minimal patient cost-

sharing required. Even when a patient has a high level of cost-sharing required for coverage, oncologists may waive copayments because of the life-threatening nature of the disease.

Further, cancer patients may have a higher price point they are willing to pay than RA patients. From a recent 2014 ZHI report, cancer patients were willing to stay on therapy and were likely to start looking for savings only when their out-ofpocket expenses were greater than $240. RA patients would start looking for savings if their out-of-pocket expenses were more than $90.

“RA tips into this space of an extremely serious disease that isn’t life-threatening in the short-term,” said Haren. “This creates a difference in the threshold above which people decide they can’t afford the drug.”

Other rheumatologic drugs saw relatively high levels of prescriptions with offset. Psoriasis patients had their medications offset 39% of the time, growth hormone and related disorders costs were reduced in 28% of the scripts, and patients receiving medications for systemic lupus erythematous had their copayments cut at a 3% rate. The weighted average for the entire sample suggested that 37% of patients had assistance with their medication payments. The average patient received $427 in assistance from copay programs. l

SAVE THE DATE This year’s NORM conference will be held September 12-13, 2014, in Louisville, KY—see page 23 in this issue for more information.

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Copay Assistance

Patients Tap into Copay Offset Programs

By Kurt Ullman, RN, MHA, BSPA

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ssisting patients with copays has become a big part of medication payment programs over the last few years. Many pharmaceutical companies view this as a way to maintain market share and help consumers cope with multiple payment tiers. Others within the pharmaceutical benefits industry are concerned, however, that coupons may encourage the use of brandname medications when generics or cheaper on-patent drugs are available, thus circumventing formulary structures. A study prepared by Visante Inc, for the Pharmaceutical Care Management Association in November 2011, suggests that the use of copay coupons could add $32 billion to the cost of drugs over the next decade.

Circumventing Formularies?

Perhaps the biggest concern within the pharmacy benefits industry is that some perceive that these types of programs circumvent formulary structures. They minimize or eliminate the effects of various copay tiers by paying the differential.

This means that expensive hightier medications cost essentially the same to the patient as the lower-tier, preferred medicines (eg, generics).

The coupons may serve as an incentive for patients to buy drugs that cost them less out of pocket, but are much more expensive for their employer and health plan.

As an example, the Visante study points to a copay coupon covering all but $4 of a person’s copayment.

This makes the patient’s cost for a $150 nonpreferred prescription the same, or possibly less, than the generic alternatives. While the consumer pays just $4, the health plan itself will still pay around $100 for the medication. This is in contrast

to a total cost to both the consumer and the plan of as little as $4 for the generic that has been supplanted.

The report also noted that re­ demption of copay offset coupons is usually outside the regular claims processing system, which may prevent employers and plan sponsors (as well as the pharmacy benefit managers [PBMs]) from detecting which enrollees are using them and to what extent.

Copay Offset Programs Help Pharmaceutical manufacturers suggest that copay offset programs (COPs) help those in need get the most appropriate medications regardless of price.

“Patients with debilitating chronic diseases such as rheumatoid arthritis (RA) are often subject to high cost-sharing, creating an insurmountable barrier to access needed treatments,” wrote Josephine Martin, executive vice president of Pharmaceutical Research and Manufacturers of America in an e-mail to Rheumatology Practice Management. “The biopharmaceutical research industry shares concerns over this burden placed on patients. Also at risk for high-cost medications are patients who need cutting-edge specialty medications for which there may be no therapeutic equivalent.”

She noted that in the absence of copay and other patient savings programs, nearly 1 of every 3 people taking specialty medicines abandoned their medications, which, in turn, resulted in poorer health outcomes.

Research cited by Ms Martin suggests that patient savings programs improve adherence. She points to a study by The Amundsen Group showing that copay programs can reduce patient medication abandonment rates by 40%.

Pharmacy Benefit Managers’ Perspective Recently, PBMs have taken steps in response to COPs. Express Scripts, Inc (ES) announced that its 2014 National Preferred Formulary (NPF) would exclude 48 products for which there is an alternative, meaning that the patient would have to pay 100% of the costs of the excluded drugs unless certain requirements are met.

Designated specialty pharmacies in UnitedHealthcare’s commercial insurance network have also been directed not to redeem copay coupons. CVS Caremark has a similar program that, as of yet, has not impacted widely used rheumatology medications.

“Today, in many therapy classes, drug choices are larger than ever,” said Riddhi Trivedi-St. Clair, senior manager for corporate communications at Express Scripts in an e-mail to Rheumatology Practice Management. “Some of these products cost (more) but offer no additional health benefit. Coupons and other copay assistance provide discounts for patients that also circumvent the formulary structure and provide incentives for patients to choose a medication that is more costly for their employer or health plan. Nearly all of the products excluded from the NPF have had copay coupons.”

ES used input from the independent professionals who comprise its Pharmacy and Therapeutics (P&T) Committee in the annual reevaluation of its formulary. They first looked at available medications from a clinical perspective with an eye toward providing access to medications in all therapy classes.

“Only after the clinical requirements have been achieved, did we start to evaluate for cost-effectiveContinued on page 20

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Wealth Management

Investing: Where to Put Your Money Now

By W. Ben Utley, CFP®, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

Y

ou make more money than you spend. It’s the right problem to have, but it’s a problem nonetheless. In fact, every new dollar of savings seems to call for a new investment strategy, but you don’t know where to begin. When you ignore the problem, cash piles up in your checking account—first $40,000, then 6 figures. Then you get nervous. If it was hard to invest a smaller sum, it seems impossible to invest more than $100,000.

Then one day, you stumble upon the headline that brought you here, hoping to find the answer. And if this were any ordinary article, you might be well on your way to making the same mistake that most of your colleagues have made at least once in their careers: they pile their money into a hot investment touted at the time. First, they buy it. Then, they watch it drop like a rock. And, months later, when the promised results fail to materialize, they sell everything and feel foolish. It gets worse as the cash continues to pile up and your question goes unanswered: “Where do I put my money now?”

The best investment strategies have nothing new about them and they work. Here are 3 investment strategies you can use over and over again, decade after decade, to make your savings last.

Stop Trading Stocks and Start Owning Markets We are sure that you have heard stories in the doctor’s lounge about how your colleagues doubled or tripled their money with their latest stock picks or how they nabbed a tax-free bond paying 5 full percentage points above average. Sounds like they are making a killing, right?

Not exactly. The chances are good that they have gotten killed on plen-

ty of trades, but physician culture won’t allow them to tell you about their blunders. We’ve seen plenty of doctors who stock-picked their way to a small fortune, but most started out with a much larger one. Instead of taking on substantial risk by betting on one stock, keep risk in check by owning a portfolio of them—the easy way.

Single stocks can go bankrupt and single bonds can go into default, wiping you out completely. Index funds, which represent ownership in hundreds if not thousands of companies, make it easy to gain instant diversification, diluting the uncompensated or “bad” risk while retaining the “good” risk that leads to rewards over the long haul.

Index funds are cheap. With operating expense ratios as low as 0.05%, you can buy an index fund and gain exposure to bonds or stocks around the world. That insignificant carrying cost also buys you the freedom to stop acting like a stockbroker and allows you to get back to serving as a healthcare provider. Savvy physicians prefer mutual funds for their tax efficiency. Since they follow a buy-and-hold approach to investing, index funds are more likely to realize tax-favored capital gains and tax-qualified dividends than more highly taxed short-term gains. This keeps your tax bill in check.

Stop Timing the Markets and Start Owning Them (All) If you have heard about index investing, you probably know about the S&P 500, a basket of stocks that represents the 500 biggest companies in the United States. The index was made famous in the 1980s and 1990s as it ran up to the dotcom bubble, then vilified in the ensuing “lost decade” when the 10-year return on

W. Ben Utley

Lawrence B. Keller

that index was close to zero.

What index hecklers fail to realize, even to this day, is that there’s more than one index. In fact, you can gain exposure to practically all the stocks and bonds on the planet by owning as few as 4 mutual funds.

Had investors done this during the past 10 years, they would have avoided some of the technology crash, found the lost decade, and enjoyed very decent returns after all.

Unfortunately, the average investor seldom receives average returns.

According to a recent study by mutual fund data company Morningstar, “the typical investor gained only 4.8 percent annualized over the ten years ended December 2013 versus 7.3 percent for the typical fund.” That’s a yawning 2.5% gap.

Why did investors miss out on fully one third of the market returns?

It’s simple. They did the same thing with their funds that your colleagues did with their stocks: they traded in and out of the market. To garner the returns advertised over the past decade, or even the last 3 decades, you would have to own them through thick and thin, no matter how dramatic or dire the news.

Invest Like a Nobel Prize Winner The main argument against an index-only strategy is that it generates merely average returns in the best-case scenario. This logic appeals Continued on page 20

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Wealth Management

Investing: Where to Put Your...Continued from page 19 to doctors who have never once settled for things that are merely average (and that’s pretty much all the physicians we’ve met).

Thanks to the research of Nobel laureate Eugene Fama, we now know it’s possible to reliably beat the averages over the long run—but it’s not free. Mr Fama, a financial luminary who founded the first small cap index mutual fund, discovered that the smaller a company is, the more likely it is to outperform a larger one. This is known as the “small cap effect,” and it is robust, having been observed in US market history as well as the return series of developed foreign stock markets and even emerging markets. Mr Fama and colleague, Kenneth French, both researchers who hail from the renowned University of Chicago Booth School of Business, also found that the stocks of cheap companies, known as “value stocks,” tend to outperform their more expensive “growth stock” peers in what is known as the “value effect.”

This effect is also robust in markets

domestic and foreign, and is available to investors using index funds.

While a small cap value tilt may add up to 4 percentage points more than the average untilted portfolio over long periods of time, it brings more volatility, too. When equity markets decline, those index funds filled with cheap little stocks take it hard, and you may wish you had never owned them. The only way to reliably garner the higher expected returns from small cap value stocks is to remain fully invested and stay the course, even when times are tough. This, too, is old news. Even though Mr Fama won the Nobel Prize in economics just last year, his research on the small cap and value effects has been public knowledge since the 1980s.

Summary These perfectly decent strategies are so mundane—so incredibly boring—that you and your colleagues may never have heard of them. After all, words like “diversified,” “tax-effi-

cient,” and “cost-effective” make lousy headlines. The good news is that you can start using a solid investment strategy and keep using it year after year, decade after decade, secure in the knowledge that you have found a permanent answer to a nagging question. Remember, the answer to good investing is more than where you put your money now. It’s where you keep it over the long haul. l W. Ben Utley, CFP®, is the lead advisor with Physician Family Financial Advisors, a fee-only financial planning firm helping doctors throughout the United States to save for college and invest for retirement. Contact him at 541-4630899 or visit www.physicianfamily.com.

Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the founder of Physician Financial Services, a New York–based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 800-481-6447 or by e-mail to Lkeller@physicianfinancialser vices.com with comments or questions.

Patients Tap into Copay Offset...Continued from page 18 ness,” said Ms Trivedi-St. Clair.

“Those more expensive products that, according to the P&T committee, offered no additional therapeutic benefit than products already on the formulary were placed on a higher tier or removed from the formulary altogether.”

She stressed that ES does realize there are what she termed “rare instances” when the on-formulary medications may not be a viable option for a specific patient. To address these issues, the company has set up an exception process.

Impact Not Understood It is not yet well understood how much of an impact formulary restric-

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tions may have on real-world clinical practice. This may be due, in part, to the newness of the initiatives that began in 2012 and have since expanded in both scope and participating programs.

The system in place also may mediate against these programs being effective or intrusive in the clinical space. Pharmacists submit claims to insurers or their managers in the primary position who return the amount that the plan covers. The COP is then processed as a secondary claim, and the PBM would have no way of knowing the particulars.

“The way COPs work is that the manufacturer wants to provide supplemental assistance to the patient

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after their primary insurance has kicked in,” said Jason Rucker, director of the Co-Pay Offset Monitor at Zitter Health Insights. “PBMs really can’t block them because they can’t prevent a secondary claim from coming through.”

Still Early It is still very early in the process, and PBMs, manufacturers, patients, insurance companies, and physicians may need to wait and see what happens in the long run. l Reference

1. Visante Inc. How Copay Coupons Could Raise Prescription Drug Costs By $32 Billion Over the Next Decade. http://www.pcmanet.org/images/sto ries/uploads/2011/Nov2011/visante%20copay%20 coupon%20study.pdf. Accessed June 2, 2014.

Physician-Hospital Alignment Series

Do’s and Don’ts in Physician-Hospital Alignment, Part 1

By Max Reiboldt, CPA, President/CEO, Coker Group, Alpharetta, GA

T

he alignment of physicians with hospitals and health systems is increasingly challenging in today’s healthcare climate. In the past, many physicians viewed hospitals as potential partners with endless channels of money by which they could augment their previous private practice incomes. Notwithstanding the compliance concerns with this approach, the economic realities are that hospitals do not have excess funds to pay physicians—at least not at the levels that many physicians expect. Moreover, the regulatory requirements of paying at fair market value and commercially reasonable rates prevail in every instance.

Despite these challenges, interest in alignments continues to expand.

And the necessity of maintaining a strong and diverse medical staff versus the threat of losing critical team members and the subsequent closure of a business line often results in hospitals/health systems making de­ cisions and promises they may not otherwise make. Accordingly, let’s briefly examine some of the key areas of consideration that must occur to prevent hospitals and physicians from falling into arrangements that are unlikely to succeed.

Pretransactional Due Diligence Before formulating the transaction, both the hospital and the physician group must be reasonably certain that they are comfortable with partnering. Often, this results from an initial review of the landscape (stage 1). Hospitals will engage consulting firms to complete a landscape review, which involves nonthreatening in­ teractions between the physicians

and hospital leadership in exploratory discussions. It is at this stage that specific issues are identified; even more importantly, an exact model is designed. That model could range from limited to moderate to fuller forms of alignment.

The initial review of the landscape should encompass some basic financial analysis to consider the historical performance of the practice. The analysis should also begin to explore what the practice will look like posttransaction through a financial pro forma, which will have a great deal to do with the model that has been selected. If multiple models are under consideration, each should have its own financial pro forma.

The alignment of physicians with hospitals and health systems is increasingly challenging in today’s healthcare climate.

Once the basic analysis is completed and the decision is made to move forward into transactional development (stage 2), a more detailed financial analysis should be prepared; this could be prepared by an independent party. That independent party should also be knowledgeable in fair market value testing for commercially reasonable rates of compensation for physicians employed by nonprofit hospitals or integrated delivery systems. The financial analysis will ultimately lead to a completed pro forma. The pro

forma analysis will address many things, not the least of which will be the hospital or delivery system’s return on investment. The fullfledged pro forma analysis will lead to the development of a term sheet that memorializes (not legally binding) the key financial terms of the transaction.

Assuming the processes continue to go well, an independent appraisal will also be needed in order to determine the fair market value of the assets and other related items of value that are included in the transaction. Depending upon the structure of the transaction, the areas of consideration could range from the entire practice entity to certain components of the practice, such as physician and staff workforce remaining in place. The independent appraisal should be specific in response to the actual structure of the proposed transaction. For example, if the transaction is a joint equity model, the appraisal would only be for a minority interest (assuming that the hospital is only buying a minority interest) of the practice. If it is a professional services agreement, there will likely be very little upfront value exchange, with the exception of the ancillary assets, which are often purchased by the hospital.

Finally, as a part of the pretrans­ actional due diligence, the hospital/ health system should complete an operational assessment of the practice or other healthcare entity. This would only be needed if they are acquiring all or most of the practice or the related ancillary service, such as an ambulatory surgery center.

Typically, a hospital/health system will be equipped with its own internal resources to review all areas of Continued on page 22

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Physician-Hospital Alignment Series

Do’s and Don’ts...Continued from page 21 operations, or they will engage an independent expert to complete that operational assessment; the operational assessment often will include a procedural coding audit.

The pretransitional due diligence process involves many facets to allow the hospital and health system to gain full undersactional of what they are getting into. From there, the parties can move toward a well-designed and legally compliant alignment transaction.

Structural Design Another key facet toward the successful development of a physician/ hospital alignment relationship is the actual design of the model. As briefly discussed, there are myriad models; each has its pros and cons, from both the hospital and physician perspectives. It is the job of the experts (often independent consultants and attorneys) who are assisting the practice and the hospital to point out the pros and cons of each model and, ultimately, to build consensus as to the best model for the particular transaction. Flexibility in model development is a key overarching point of view in achieving a positive result. Although employment is often the preferred model and is the outcome of the majority of transactions, this arrangement should not be forced on the physicians.

Key economic and noneconomic terms and conditions should be considered. Ultimately, these will be formalized in the definitive agreements; prior to that, a term sheet or letter of intent (LOI) or memo of understanding should detail these terms and conditions. Often, we separate these into 3 major classifications: • Economic • Governance/leadership • Unwind provisions With the term sheet and LOI draft in place, these major areas of review

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have been considered and are a significant part of the overall foundation that is being formed. (It should be noted that several of the items discussed under pretransactional due diligence would be completed simultaneously with the matters we are discussing at this point under structural design.)

Next, an additional financial analysis should be considered. While analysis under pretransactional due diligence is absolutely essential, another financial analysis—the

It is the job of the experts who are assisting the practice and the hospital to point out the pros and cons of each model and, ultimately, to build consensus.

“impact analysis”—should be completed by the hospital. This is done by the hospital as an internal document that incorporates the overall contributions that the transaction will entail—meaning that there are some portions of the transaction that will likely not appropriately (or legally) be considered within the pro forma process. For example, if the hospital acquires the ancillary services from the practice as a part of the alignment transaction and they choose to convert these to hospital outpatient department (HOPD) billing structure for Medicare and Medicaid, and they move these out of the actual integrated entity, those performance results cannot be considered in order to determine the

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physicians’ compensation within the alignment model. However, the hospital should certainly consider the impact of having these assets and being able to realize this revenue going forward. It should also be noted that often this revenue (under HOPD rates) is much better than that paid to private practices. In short, the overall return on investment (“downstream revenue”) is better for the hospital. Although this should be considered in the overall impact analysis, it cannot be a part of the actual direct transaction for legal and compliance purposes.

Finally, within the structural design and assuming all of these prior analyses have been thoroughly reviewed, and both parties are still interested in proceeding (note that at any point during this process either party can drop out or change the transaction structure), the definitive agreement drafting should be completed. This should include utilization of legal counsel and the consultant’s support to formulate the actual legal documents that will be executed at closing.

Such legal documents will vary, but usually will include an asset purchase agreement, or, if the entity (or a part of the entity) is being purchased, a stock purchase agreement. Other agreements could be tied to management services, operating agreements, employment agreements, professional services contracts, etc. Again, these are all a part of the definitive agreement process that must be ultimately decided upon and responded to, based upon the actual model structure.

Part 1 of this 3-part series has focused on pretransactional due diligence and structural design processes as they pertain to physician–hospital alignments.

Part 2 of this series will address governance and compensation plans; the final installment will discuss ongoing relationships and planning for a potential “divorce.” l

Time to Get on TRACK and RACE to Excellence Together!

o National O r ganizat ion of R heumatolo g y Ma na gers Racing to Rheumatology Excellence Friday, September 12, 2014 and Saturday, September 13, 2014 Increase your odds of “being in the winner’s circle” by joining us for the 2014 NORM Conference where nationally known speakers will help NORM members race on the fast track rather than the sloppy track. Presentations and breakouts on topics such as MU2, OSHA, Customer Service, Physician and Team Engagement, and Financial Management of your practice will help your practice win the race. The conference will end with a presentation on Understanding the Impact of ICD-10 and an ICD-10 workshop stocked with take-aways for your practice. This year NORM has added 6 product theatres offering attendees the opportunity to be hands-on with some products.

NORM membership also provides access to the NORM listserv and education portal. The listserv allows NORM members to seek answers to their practice and nationwide issues from members across the country. The educational portal provides access to training and informational presentations as well as sample documents.

Conference Registration is Now Open | 2014 Dues and Conference Registration $250

For more information contact NORM at info@normgroup.org or visit our website www.normgroup.org “Of all the practice management resources out there, none are as relevant and as valuable to me as my NORM membership.

With benefits like the member listserv and an affordable annual conference, the NORM group provides a forum for mentorship, education, professional feedback, cutting edge ideas and inspiration.” Jay Salliotte

Diamond Level Corporate Member - Janssen Biotech, Inc

Platinum Level Corporate Member - Celgene Corp

Drug Update

Otrexup (Methotrexate) Injection:

Novel Methotrexate Delivery System for Patients with Rheumatoid Arthritis

By Lisa A. Raedler, PhD, RPh, Medical Writer

R

heumatoid arthritis (RA) is a chronic, systemic autoimmune disease that affects at least 1.3 million adults in the United States.1 Symptoms include pain, stiffness, swelling, and limited motion and function of many joints, particularly the small joints in the hands and feet.1 A diagnosis of RA is made on the basis of symptoms, physical examination results, and blood tests that are positive for anemia, rheumatoid factor, antibodies, and elevated erythrocyte sedimentation rate.1 Continued inflammation of the synovium can lead to cartilage and bone damage.1,2 Although the etiology of RA is unknown, there is an association with genetic factors and environmental exposures.2 Risk factors include smoking, reproductive hormone exposures, dietary factors, and microbial exposure, as well as having human leukocyte antigen class II genotypes (eg, DR4 and DRB1 molecules).2 In addition to affecting the functioning and quality of life of patients, RA exacts a heavy economic toll on patients, employers, and payers.

A recent study highlights the significant cost borne by American workers who live with RA and their employers.3 The research was conducted using a database of US employees’ administrative healthcare and payroll data for individuals enrolled in an employer-sponsored insurance plan for at least 1 year.3 Compared with employees who do not have RA, an employee with RA incurs approximately $5200

more in annual healthcare costs.3 Workers with RA also pay an average of $1500 more per person for prescription medications annually, and are absent from work approximately 3.5 more days annually.3 On the whole, patients with RA cost their employers across the United States approximately $5.8 billion annually.3 Today’s treatment of RA is symptom-based and often requires a combination of agents.1 Typically, therapy begins with disease-modifying antirheumatic drugs (DMARDs), such as methotrexate, leflunomide, hydroxychloroquine, or sulfasalazine.1 DMARDs are administered along with nonsteroidal anti-inflammatory drugs (NSAIDs) and/or low-dose corticosteroids to reduce swelling, pain, and fever.1 The treatment course for more serious cases of RA includes biologic agents, which are also considered DMARDs, that target specific aspects of the immune system.1 These drugs include abatacept (Orencia), ada­ limumab (Humira), anakinra (Kineret), certolizumab (Cimzia), etanercept (Enbrel), golimumab (Simponi), infliximab (Remicade), rituximab (Rituxan), and toci­ lizumab (Actemra). The most recently approved agent for RA in adults, tofacitinib (Xeljanz), is an oral inhibitor of Janus kinase– mediated cell signaling.4 As unique biomarkers, genetic defects, and drug targets are identified, the development of novel RA agents continues. A recent genome-wide association study

Copyright © 2014 American Health & Drug Benefits. All rights reserved.

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identified 42 new genes that confer the risk for RA at a genome-wide level of significance, bringing the total of known RA risk genes to 101.5 Although many current RA therapies target these genes, these findings suggest that drugs that are currently approved for other indications may be repurposed for use in patients with RA.5 Other novel targeting agents, including inhibitors of granulocyte-macrophage colony-stimulating factor receptors, have been shown to suppress cytokine responses in patients with RA.6

Otrexup: Novel Delivery of Methotrexate In October 2013, the US Food and Drug Administration (FDA) approved the first methotrexate injection (MTXI) for subcutaneous (SC) use (Otrexup; Antares Pharma).7 This once-weekly self-administered injection is indicated for adults with severe active RA who have had inadequate response to or are intolerant of first-line therapy.7 MTXI was also approved for use in children with active polyarticular juvenile idiopathic arthritis.7 The approval of MTXI was based on the demonstration of bioavailability in a 12-week, open-label, crossover study comparing the relative bioavailability of MTXI with oral methotrexate.8 Data from this study were presented at the 2013 annual meeting of the American College of Rheu­ma­tology.

Originally developed as an oncology drug, methotrexate has become a cornerstone in the treatment of RA.9 In a recent inter-

Drug Update

view regarding his experience in the study of MTXI, Michael Schiff, MD, Clinical Professor of Medicine in the Division of Rheumatology at the University of Colorado, stated, “This new delivery system for methotrexate provides a welcome option for physicians and their patients to continue effective use of methotrexate….The availability of an easy and safe way to administer subcutaneous methotrexate may…enable more patients to realize the possibility of continued disease control.”7 The use of parenteral methotrexate for the treatment of RA is less popular as a result of the challenges related to self-administration.

Patients with RA may have compromised manual dexterity, needle phobia, and/or a lack of confidence in safely self-injecting with a vial, a needle, or a syringe, which can be barriers to use.7 Kevin Deane, MD, of the Division of Rheumatology at the University of Colorado stated, “Injectable [methotrexate] to date has come in a large vial, and [the] patient draws up medication and injects it....Drawing up and administering this medication may be somewhat difficult for some patients to do, especially with arthritic conditions.”10

Mechanism of Action Methotrexate, an inhibitor of dihydrofolic acid reductase, interferes with DNA synthesis, repair, and cellular replication.11 Cells that are actively proliferating are particularly susceptible to these effects.

The mechanism of action of methotrexate in RA is unknown. It may work by altering immune function.11 Dosing and Administration MTXI is a single-dose, easy-touse autoinjector for once-weekly SC use.11 It is available in doses ranging from 10 mg to 25 mg in 5-mg

Table 1. Relative Bioavailability of Subcutaneous Methotrexate versus Oral Methotrexate MTXI dose, mg Relative bioavailability, % 10

121

15

114

20

131

25

141

MTXI indicates methotrexate injection.

Source: Schiff MH, et al. Arthritis Rheum. 2013;65(10 suppl):S337-S338.

increments and is administered in the abdomen or thigh.11 The MTXI dose can be adjusted gradually for optimal outcomes.

Therapeutic response to methotrexate is usually seen within 3 to 6 weeks and continues for 12 weeks or more.11 The optimal duration of MTXI therapy is unknown.11 Healthcare professionals should ensure that patients understand that MTXI is administered once weekly.

The daily use of methotrexate has resulted in fatal toxicity.11

Clinical Trials Bioavailability Study The bioavailability of MTXI was assessed in an open-label, crossover study in which 49 adults with RA who had been receiving methotrexate for 3 months or more were given 10 mg, 15 mg, 20 mg, or 25 mg of methotrexate.8 They were randomized to receive either oral methotrexate, MTXI injected in the abdomen, or MTXI injected in the thigh.8 Blood samples were collected for analysis before the drug’s administration and at 13 time points of 15 minutes to 12 hours after drug administration.8 The average age of patients with RA who enrolled in the bioavailability study was 61 years and they had been diagnosed with RA for an average of 13 years.8 Their mean body mass index was 30.7 kg/m2.8

Pharmacokinetic parameters of interest included the area under the plasma concentration time curve (AUC), the maximum drug concentration, and the time of occurrence for maximum drug concentration.

Safety was determined using the incidence of treatment-emergent adverse events (AEs), including injection-site reactions, as well as by monitoring laboratory parameters and vital signs.8 The analysis of pharmacokinetic parameters demonstrated that 4 hours after administration, the bioavailability of MTXI (administered in the thigh) was consistently greater than oral methotrexate at all dose levels (10-25 mg).8 At doses of 10 mg, 15 mg, 20 mg, and 25 mg, the relative bioavailability calculations (AUC of MTXI vs oral methotrexate) were 121%, 114%, 131%, and 141%, respectively, as summarized in Table 1.8 No bioavailability plateau was seen for MTXI, whereas the bioavailability of oral methotrexate plateaued at a dose of 15 mg.8

Phase 2 Clinical Trial A phase 2, multicenter, open-label, single-dose, single-arm, in-clinic study enrolled 101 adults with RA to evaluate the ease of use of MTXI.12 The autoinjected product was tested with the intention of addressing the concerns of patients with RA regarding self-administerContinued on page 28

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By Kyle C. Harne r, MD, Mana Arthri

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GEMENT

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ging Partner, Carolina nville, NC

tis Center, Gree

ased on group preferences and state laws, rheum atology physi- patients have limited option cians may s for pain control. Becau se of this, the cotic prescriptionor may not write narcians 3 physis for patients chronic pain as part of for in our practice prescribe narcot management. patients who In North Caroli we feel need long-t ics na, primary care Eastern arthritis pain erm seldom FOR OFFICE write such prescr providers col to manag control. We have a protoADMINISTR e these prescr iptions, and ATORS, RHEU outside of pain iption in s that is compl manag MATOLOGISTS, iance ement PHYSICIAN clinics, Medical Board with the North Carolina ASSISTANTS, .

AND NURSE PRAC ContinuTITIO NERS ed on page From the 8 Editor

The S Mode

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ancy Ellis’ day morning walk starts with a office to greet around the colleagues and get a feel for pressin The administrato g issues of the day. r of a busy rheum ogy practice, atolMs of the 26 people Ellis may run into any who work at Piedm ont Continued on page

5

tology

By Iris W. Nicho ls, President, Managers; National Orga Editor-in-Ch nization for ief, Rheumato Rheumatology logy Practice Manageme e are all aware nt of the many challenges and opportunities mance indicators that exami we face in tice quality rheumatolog as well as costs, ne pracpractices. As y evaluate we and we our practices articles, news see from the countless by comparing them to yester blurbs, and listser day, ings, we all encounter simila v post- exist today, and looking at how they We strive for preparing them r things. morro for tow. I recently (our physicians quality improvement returned from meeting where are known to a we be in this area), we have ongoin leaders together to meet discussed partnering g perfor- I these challenges. outlined my thoughts to prepar As e for

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THE NEW O T N O LOG TOLOGY T A M U E H R AGEMEN N A M E C PRACTI ITE TODAY! WEBS

Drug Update

Otrexup (Methotrexate) Injection...Continued from page 25 Table 2. System-Specific Warnings and Precautions for Subcutaneous Methotrexate Risk category

Description of potential risk

Guidance

Organ-system toxicity

• MTXI has the potential for serious toxicity; patients using MTXI should be closely monitored for bone marrow, liver, lung, and kidney toxicities. Toxic effects may be related to dose or frequency at any dose

• If adverse reactions occur, MTXI should be discontinued or the dose reduced; correction with leuco­vorin calcium and/or acute intermittent hemodialysis with a high-flux dialyzer may be warranted. If MTXI therapy is reinstituted, it should be done cautiously • Because methotrexate has not been well studied in older individuals, relatively low doses should be considered in elderly patients and they should be closely monitored

Gastrointestinal • MTXI should be used with extreme caution in patients with peptic ulcer disease or ulcerative colitis • Unexpectedly severe and at times fatal gastrointestinal toxicity have been documented in patients taking methotrexate (usually high dose) in combination with some NSAIDs

• Interruption of MTXI therapy is necessary if diarrhea and ulcerative stomatitis occur • Dehydration resulting from vomiting, diarrhea, or stomatitis warrants discontinuation of MTXI until recovery

Hematologic

• Because MTXI can suppress hematopoiesis, anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia, and/or thrombocytopenia can occur. In controlled clinical trials conducted with a different formulation of methotrexate in 128 patients with RA, 2 patients had leukopenia, 6 had thrombocytopenia, and 2 had pancytopenia • When administered with some NSAIDs, high doses of MTXI may cause severe and sometimes fatal bone marrow suppression and aplastic anemia • Patients with severe granulocytopenia and fever should be evaluated as soon as possible. Such patients usually require parenteral broad-spectrum antibiotic therapy

• MTXI should be used with extreme caution in patients with preexisting hematopoietic impairment. The drug should be stopped immediately if a significant drop in blood counts is observed

Hepatic

• MTXI can cause hepatotoxicity in patients with RA, ranging from elevated transaminases to fibrosis and cirrhosis • In RA, methotrexate hepatotoxicity may be associated with age at first use and duration of therapy. Other risk factors, such as total cumulative dose, diabetes, and advanced age, as well as lifestyle factors including alcoholism and obesity may be associated, but have not been confirmed • Liver function tests should be performed at baseline and at 4- to 8-week intervals in patients receiving MTXI for RA • Patients with a history of excessive alcohol use, abnormal baseline liver function test values, or chronic hepatitis B or C infection should undergo liver biopsy before MTXI treatment • During treatment, liver biopsy should be performed if liver function test abnormalities are persistent or if serum albumin levels fall below the normal range • MTXI should be discontinued in patients who show persistent abnormal liver function tests, those who do not consent to liver biopsy, and in any patient whose liver biopsy exhibits moderateto-severe changes

• Special caution should be taken in patients with preexisting liver damage and impaired hepatic function

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Drug Update

Table 2. System-Specific Warnings and Precautions for Subcutaneous Methotrexate (Continued) Risk category

Description of potential risk

Guidance

Infection

• Patients with an active infection should use MTXI with extreme caution • Opportunistic infections, especially Pneumocystis pneumonia, may occur with MTXI

• Live virus vaccines are not recommended and may be ineffective when given during MTXI therapy

Neurologic

• Leukoencephalopathy after intravenous methotrexate administration has been reported in patients who have had craniospinal irradiation. Discontinuation of methotrexate does not always resolve neurotoxicity

Neurologic

• Transient acute neurologic syndrome has been reported in patients treated with high-dose methotrexate. This strokelike encephalopathy can manifest as confusion, hemiparesis, transient blindness, seizures, and coma. Its exact cause is unknown

Pulmonary

• Use of methotrexate may result in lung disease, including acute • If pulmonary symptoms are observed, MTXI treatment should be or chronic interstitial pneumonitis. This may occur at any time interrupted and the patient should be during therapy and has occurred at low doses of methotrexate. closely monitored Lung disease may not be fully reversible and can be fatal • Symptoms of pulmonary distress, especially a dry nonproductive cough, and nonspecific pneumonitis occurring during MTXI therapy may indicate a dangerous lesion • Other symptoms can include fever, cough, dyspnea, hypoxemia, and an infiltrate on chest x-ray. Infection (pneumonia) must be excluded

Renal

• High doses of methotrexate used in the treatment of osteosarcoma can cause renal damage that may lead to acute renal failure

Skin

• Dermatologic reactions, including severe reactions and fatalities, have been reported in children and adults within days of taking oral, intramuscular, intravenous, or intrathecal methotrexate administration at any dose

Dizziness and fatigue

• MTXI use may lead to dizziness and fatigue

• Renal function, adequate hydration, urine alkalini­zation, and levels of serum methotrexate and creatinine should be monitored

• Patients should be cautious when driving or using machinery

MTXI indicates methotrexate injection; NSAIDs, nonsteroidal anti-inflammatory drugs; RA, rheumatoid arthritis.

Source: Otrexup (methotrexate) injection prescribing information; 2013.

ing methotrexate using a conventional vial and syringe.12 The patients in the trial received MTXI at a dose of 10 mg, 15 mg, 20 mg, or 25 mg weekly.12 Dosing was determined by investigators based on each patient’s previous methotrexate regimen and disease status (ie, controlled or uncontrolled) at the time of study enrollment.

Of the 101 patients enrolled, 99 patients were evaluable.12 Most

patients (79%) were female, with an average age of 61 years.12 These patients had been diagnosed with RA for an average of 13 years.12 All patients had received methotrexate for at least 3 months before enrolling in the study.12 Overall, 20% of patients had received SC methotrexate, and their functional status ranged from mild to severe; 89% were in American College of Rheumatology Functional Class II or III.12

The primary outcome measure in this phase 2 trial of MTXI was pain associated with SC administration as measured using a 100-mm visual analog scale (VAS).12 The administration sites were evaluated before administration and at 15 minutes, 1 hour, 6 hours, and 24 hours after self-ad­ministration.12 The mean administration-site pain ratings for all enrolled patients (N = 101) were 3.6 on day 1 and 1.4 on day Continued on page 30

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Drug Update

Otrexup (Methotrexate) Injection...Continued from page 29 2 (standard deviations, ±9.1 and ±3.2, respectively).12 Of the 99 evaluable patients, 94% reported VAS scores of ≤10 on day 1, and 87% had scores of ≤5 on day 1.12 All 99 patients handled the autoinjector successfully.12 Of 404 skin sites that were evaluated after MTXI administration, 92% reported no erythema, with the balance showing “very slight, barely perceptible” erythema.12 Three patients experienced AEs while taking MTXI, including sick sinus syndrome, exostosis, and headache.12 None of these was considered to be related to the study drug.12

Safety Methotrexate and MTXI were safe and well tolerated in the bioavailability study.8 The few AEs that were observed with MTXI were deemed transient and manageable.

None required medical treatment.8 Two serious AEs were deemed unrelated to treatment, including 1 death from myocardial infarction in a 79-year-old man with a history of heart disease.8 Contraindications MTXI is contraindicated in pregnant women, nursing mothers, patients with alcoholism or liver disease, patients with immunodeficiency syndromes, patients with preexisting blood dyscrasias, and patients with hypersensitivity to methotrexate.11 Warnings and Precautions Boxed warning. Like the oral formulation of methotrexate, MTXI labeling includes a boxed warning for multiple safety risks, including embryo-fetal toxicity and death.11 These warnings include11: • Serious toxic reactions and death; patients taking methotrexate

should be closely monitored for bone marrow, liver, lung, skin, and kidney toxicities • Fetal death and congenital anomalies; methotrexate is contraindicated in pregnancy • Unexpectedly severe and sometimes fatal bone marrow suppression, aplastic anemia, and gastrointestinal toxicity; these events were reported when methotrexate and some NSAIDs were administered concurrently • Hepatotoxicity, fibrosis, and cirrhosis after prolonged use • Interstitial pneumonitis • Diarrhea, ulcerative stomatitis, hemorrhagic enteritis, and death from intestinal perforation • Severe and occasionally fatal skin reactions • Potentially fatal opportunistic infections.

Laboratory tests needed.

Patients who are candidates for MTXI should undergo a complete blood count with differential and platelet counts, hepatic enzymes, renal function tests, and a chest x-ray before initiating therapy.

During MTXI therapy, clinicians should monitor hematology parameters at least monthly, and monitor renal and liver function parameters every 1 to 2 months.

Embryo-fetal toxicity. Fetal death and congenital anomalies have been reported with methotrexate use. MTXI is not recommended for women of childbearing age unless its benefits outweigh risks.

Steps to avoid conception should be taken if either partner is receiving MTXI therapy.

Malignant lymphomas. NonHodg­kin lymphoma and other tumors have been observed in patients taking low-dose oral methotrexate. In some cases, however, malignancies that arose during treatment regressed com-

pletely after methotrexate withdrawal.

Before initiating antilymphoma treatment, MTXI should be discontinued.

Additional warnings. Additional warnings and precautions related to MTXI include organ-system toxicity, infection, skin reactions, dizziness and fatigue, malignant lymphomas, as well as gastrointestinal, hematologic, hepatic, neurologic, pulmonary, and renal complications. Additional information regarding these warnings and precautions is listed in Table 2.

Conclusion The FDA approval of a new delivery system for the administration of methotrexate adds a new and convenient treatment option for patients with RA. Although the literature documents the clinical utility of SC methotrexate in patients with active RA, this dosing alternative is often overlooked by clinicians.

Methotrexate administered subcutaneously using an autoinjector is a well-tolerated, effective, and nearly pain-free alternative for patients with severe RA who have had inadequate response to or who are intolerant of first-line therapy. In addition to higher drug exposure levels with MTXI, easy self-administration of the medication with this first-in-class autoinjector may help to improve patient adherence and overall clinical outcomes. l References

1. Ruderman E, Tambar S. Rheumatoid arthritis.

Up­dated August 2012. www.rheumatology.org/practice/ clinical/patients/diseases_and_conditions/ra.asp.

Accessed January 4, 2014.

2. Centers for Disease Control and Prevention.

Rheumatoid arthritis. Updated November 19, 2012. www.cdc.gov/arthritis/basics/rheumatoid.htm. Accessed January 4, 2014.

3. Kleinman NL, Cifaldi MA, Smeeding JE, et al.

Annual incremental health benefit costs and absenteeism among employees with and without rheumatoid arthritis. J Occup Environ Med. 2013;55:240-244.

4. Xeljanz (tofacitinib) tablets [prescribing information]. New York, NY: Pfizer Inc; November 2013.

Continued on page 32

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RHEUMATology Practice Management

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Invitation to Join the RPM Editorial Board The publishers of Rheumatology Practice Management™ (RPM) are inviting qualified rheumatology practice owners and administrators to participate as members of the RPM Editorial Board. As an Editorial Board member, you will play an active role in helping to shape the content of this exciting new publication.

Rheumatology Practice Management is a niche publication focused on process solutions for rheumatology practices. RPM is designed to provide the rheumatology care team—medical, practice administrators, coders, and billers—with the knowledge and skills required to keep abreast of today’s fast-changing business environment, allowing practice professionals more time to concentrate on high-quality patient care. Each issue of RPM will focus on various areas of rheumatology practice, featuring current topics such as: • Healthcare technology • Models of care • Staffing • Reimbursement and coding • Drug updates

PROCES APRIL 201 4

S IMPROV

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EMENTS

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Piedmont Arthritis C lin

ic: A Conver sa Nancy Ell tion with is, MBA/M HA, Practice Administr ator

Take advantage of this unique opportunity to help your peers and enhance your professional reputation by becoming the newest member of the RPM Editorial Board. an affiliate of

E PATIENT CARE ™

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Challeng e a New Ancs of Starting illary Serv

By Kyle C. ice Ha Arthritis Ce rner, MD, Manag ing

VOLuME

2 • NuMB ER

NAGEMEN T

nter, Gre Partner, Ca enville, NC rolina ased on gro up prefere state laws, nce rheumatology s and patients hav cians may e lim physi- con or may trol. Becaus ited options for pain cotic prescri not write nar e ptio chronic pain ns for patients as par - cians in our pra of this, the 3 physictice t of managemen North Car t. In Eastern for patients who we prescribe narcotics olin feel nee arthritis pain seldom wri a, primary care provid control. We d long-term te such pre ers col to FOR OFFIC out scri man side E ADMINIST ptions, age these pre have a protoof pain man RATORS, scriptions tha agement clinand in compliance RHEUMATO t is with the No ics, Medica LOGISTS, rth Carolin l Boa rd.

PHYSICIAN a ASSISTAN From the TS, AND NU Continued on Editor RSE PR page 8 ACTITION ERS

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ancy Ellis’ day starts morning wit walk around h a office the get a feel for to greet colleagues and The adminis pressing issues of the day. trator of a busy rheum ogy practic atole, Ms Ellis may of the 26 peo ple who wor run into any k at Piedm ont Cont inued on page

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By Iris W. Nic Managers hols, President, Na tional Org ; Editor-in-C anization hief, Rhe for Rheum umatolog atology y Practic e are all awa e Manag re of the man ement challen y

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ges and opp ortuniti we practices. As face in rheumato es log articles, new we see from the countle y s blurbs, and ss ings, we all listserv pos We strive encounter similar thin tfor quality gs. (our physici imp roveme ans are kno wn to be lead nt in this area ), we have ers ongoing per for-

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mance ind icat tice quality ors that examine pra evaluate our as well as costs, and cwe them to yest practices by compar erday, lookin ing exist today, and prepar g at how they ing them for morrow. I rece tomeeting whe ntly returned from re we discusse a together to meet these d partnering I outlined my though challenges. As ts to prepar e for Cont inued on page

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Na t ion al O R he um ato r gan iz at ion of o lo g y Ma n a ger s ©2014 Eng age Healthc are Commun icat

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For consideration to become an Editorial Board member, please complete the form below and fax to 732-992-1881 or e-mail to acooper@the-lynx-group.com _______________________________________________________________________________________ First Name

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Rheumatology Practice Management™ 1249 South River Road, Suite 202A, Cranbury, NJ 08512

RPMedit_61014

The ACA Exchanges

MGMA Survey Reveals Drawbacks to Participation in ACA Insurance Exchange Program Networks

By Rosemary Frei, MSc

T

he challenges involved with the start of implementation of the Affordable Care Act (ACA)’s insurance exchange program are evident in the responses to an April 2014 survey by the Medical Group Management Association (MGMA).1 There were 728 respondents to the survey, representing more than 40,000 physicians. A majority (59.4%) of respondents viewed ACA insurance exchanges as being unfavorable to their practices, and most said that payment rates are no higher than those offered from traditional commercial products or traditional Medicare. Furthermore, 87.6% reported difficulty identifying whether patients had ACA exchange coverage. Most respondents also said that it is more difficult than with traditional insurance products to accomplish tasks such as verifying patient eligibility and obtaining information about patients’ provider networks to facilitate referrals.

“Some of these things I think are growing pains,” said Allison Brennan, MPP, senior advocacy advisor, MGMA, Washington, DC. “This is the first year. It is a transition for practices and patients and the insurance

Allison Brennan, MPP

industry. So, some of these are going to get better over time.”

Ms Brennan and colleagues

included the survey in an e-newsletter that they e-mailed to all 22,500 members of the MGMA. Although the response rate was only 3.2%, respondents hailed from all but 4 states and were from 42 specialties. Their practices included multispecialty practices with primary and specialty care (19.3%), orthopedic surgery practices (10%), family practices (8.3%), and obstetrics/gynecology practices (6.6%). Approximately three-quarters (75.1%) were independent medical practices, and the mean practice size was 55.7 full-time– equivalent physicians.

These are roughly similar proportions to those from the more than 1000 physician practices that responded to a September 2013 survey by MGMA.2 The earlier survey was intended to determine how practice administrators viewed the impending start of patient purchase of ACA insurance exchange products. The April 2014 survey results indicate that 15.1% of respon-

Drug Update

Otrexup (Methotrexate)...Continued from page 30 5. Okada Y, Wu D, Trynka G, et al. Genetics of rheumatoid arthritis contributes to biology and drug discovery. Nature. 2013 Dec 25 [Epub ahead of print].

6. Burmester GR, Feist E, Sleeman MA, et al.

Mavrilimumab, a human monoclonal antibody targeting GM-CSF receptor-α, in subjects with rheumatoid arthritis: a randomised, double-blind, placebo-controlled, phase I, first-in-human study. Ann Rheum Dis. 2011;70:1542-1549.

7. Antares Pharma, Inc. Otrexup (methotrexate) injection approved by FDA: a new treatment for adults with rheumatoid arthritis, children with polyarticular idiopathic arthritis, and adults with psoriasis.

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Press release. October 14, 2013. www.antarespharma. com/files/8613/8175/5363/OTREXUP_FDA_Approval. pdf. Accessed January 4, 2014.

8. Schiff MH, Simon LS, Freundlich B, et al. Drug exposure limitations of oral methotrexate (MTX) at doses >15 mgs may be overcome by using a subcutaneous MTX auto-injector in patients with rheumatoid arthritis (RA). Arthritis Rheum. 2013;65(10 suppl):S337-S338.

9. Gower T. Understanding methotrexate, a cornerstone in RA treatment: how did a cancer drug become a staple in rheumatoid arthritis treatment? www. arthritistoday.org/about-arthritis/types-of-arthritis/ rheumatoid-arthritis/treatment-plan/treatment-

RHEUMATology Practice Management

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choices/understanding-methotrexate.php. Accessed January 5, 2014.

10. Brooks M. FDA OKs Methotrexate Autoinjector (Otrexup). Medscape. October 18, 2013. www.medscape. com/viewarticle/812821. Accessed January 28, 2014.

11. Otrexup (methotrexate) injection [prescribing information]. Ewing, NJ: Antares Pharma, Inc; October 2013.

12. Kivitz AJ, McLain D, Hill J, et al. Nearly pain free self-administration of methotrexate using an investigational auto-injector: results of a phase-2 clinical trial in rheumatoid arthritis patients with mild-to-severe functional limitations. Arthritis Rheum.

2013;65(10 suppl):S565.

The ACA Exchanges

dents regard the ACA insurance exchanges as very unfavorable to their practices, and 44.3% view them as unfavorable.

Approximately three-quarters (76.5%) of respondents said that their practices are participating with new health insurance products under the ACA. The main reasons cited for participation are remaining competitive in the local market, replacing current charity care when uninsured patients obtain coverage, and providing care to underserved patient populations. The top reason cited for nonparticipation was the financial liability represented by the 90-day grace period for ACA exchange enrollees.

Among respondents whose practices are participating, 84.8% offer coverage through 5 or fewer products. Only 19.9% of respondents, however, said that their practices had been excluded from a network in which they would like to have been included.

“I think it’s a 2-way street with the insurer asking the practice if they want to be in the network.

Practices also have to evaluate whether the network opportunity is a good one for the practice in terms of reimbursement and also administrative burdens,” noted Ms Brennan.

Just 25.8% of respondents said that their practice’s patient numbers had increased under the ACA, and approximately one-tenth (10.8%) said that their patient numbers had fallen. Furthermore, approximately one-third of respondents reported that payment rates under the ACA exchanges were somewhat lower than or equal to average payment rates from all of their traditional commercial contracts, at 32% and 36.6%, respectively. Just under half (41.8%) said that rates were equal

to those from traditional commercial products offered by the same payers. The situation was somewhat better compared with traditional Medicare and Medicaid, with 30.1% and 46.4% of practices, respectively, reporting higher reimbursement with the new exchanges than with these government programs.

When Ms Brennan and colleagues probed the practical aspects of the implementation, they found an abundance of pain for practices

“Some of these things I think are growing pains. This is the first year. It is a transition for practices and patients and the insurance industry.

So, some of these are going to get better over time.”

—Allison Brennan, MPP

and patients. Approximately onethird (31.5%) of respondents said that it has been very or extremely difficult to distinguish between patients with ACA insurance coverage versus traditional commercial health insurance not related to ACA exchanges, whereas 56.1% found it slightly or moderately difficult. Only 12.4% said it was not at all difficult. Furthermore, 63.2% have found it more difficult to verify patient eligibility for coverage, 62.3% said it was more difficult to obtain cost-sharing information, and 58.6% have found obtaining

June 2014

I

information about the plan’s provider network to facilitate referrals to be more difficult than with traditional commercial coverage.

“We are going to have to hire additional staff just to manage the insurance verification process,” wrote one respondent in the comments section of the survey.

Fully 40.9% of those who completed the survey said that their practices had been unable to treat some patients, because their practices were not included in those patients’ insurance exchange networks. In addition, 94.8% of respondents said that it was likely that patients have high deductibles with the new products compared with traditional commercial coverage.

“We are consistently denied ‘out of network’ approvals for the very sick who truly need to continue their care with providers who have worked with the patient for years,” wrote a respondent; another indicated that “payer directories [of providers in the practices’ networks] are woefully inaccurate and impossible to rely on.”

Ms Brennan said that she and her colleagues have heard these complaints from a number of providers, and that they represent significant problems for patients and physicians.

However, she said that these difficulties, like most of the others associated with the early days of exchange network use, are being worked on and should improve over time. l

References

1. Medical Group Management Association. MGMA ACA exchange implementation survey report. May 2014. www.mgma.com/government-affairs/issues-over view/aca/aca-exchange-implementation-report/acasurveyreport_online_2?ext=.pdf. Accessed June 5, 2014.

2.

Medical Group Management Association Legislative and Executive Advocacy Response Network (LEARN). ACA insurance exchange implementation, Sept. 2013. www.mgma.com/Libraries/ Assets/Government%20Affairs/Advocacy/LEARN/ ACA-Exchange-Implementation-LEARN.pdf.

Accessed June 5, 2014.

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Best Practices

Bone Mineral Density Should Be Checked in All Hypogonadal Men

By Rosemary Frei, MSc

Andrew McCullough

A

Igor Sorokin

recent retrospective study of 114 patients with hypogonadism has led to the conclusion that men with this condition should be screened with dual-energy x-ray absorptiometry (DEXA) for low bone mineral density (BMD). Almost half of the men who participated in this study with testosterone levels below 300 ng/dL were found in the retrospective chart review to have either osteopenia or osteoporosis.1 Presented at the American Society of Andrology’s 2014 Annual Meeting, the study examined BMD scans on patients with clinical hypogonadism. Participants presented with clinical symptoms as well as biochemical deficiencies. Hypogonadism among the older adult male population is expected to increase in coming years; the mean ± standard deviation age of the cohort in this study was 48.3 ± 13.7 years.1,2 “Even though the Endocrine Society’s 2010 guidelines state that hypogonadal men should get DEXA scans only when they have severe testosterone deficiency – that is, below 150 ng/dL – we found you still have just as much of a chance of having hypogonadism below 300 ng/dL, and no levels below this are predictive of having worse BMD,” Igor Sorokin, MD, third year urology resident at the Albany Medical College and lead author of a poster presentation

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on the results, told Rheumatology Practice Management. “The study confirms that any male coming to your clinic with hypogonadism should get a baseline DEXA regardless of previous treatment.”3 Hypogonadism is associated with a number of comorbidities; symptoms include reduced libido/erectile dysfunction, reduced muscle mass and strength, increased adiposity, and depressed mood and fatigue. It has also long been recognized as a risk factor for osteoporosis and osteopenia. However, there has been very

Hypogonadism has long been recognized as a risk factor for osteoporosis and osteopenia. However, there has been very little investigation of the strength of this association and of what factors are the strongest predictors of low BMD.

little investigation of the strength of this association and of what factors are the strongest predictors of low BMD.1,2 Andrew McCullough, MD, surgery professor, Division of Urology, Albany Medical College, led the team who reviewed the records of 114 consecutive patients who were being treated for hypogonadism between February 2011 and Septem-

RHEUMATology Practice Management

I June 2014

ber 2013 at the Men’s Health Center. Hypogonadism is defined as the presence of both symptoms and serum testosterone levels of <300 ng/ dL. The subjects had all undergone BMD assessment.1 Forty-four (38.6%) of the men had been found on DEXA screening to have osteopenia and 9 (7.9%) had osteoporosis. Their mean testosterone level at diagnosis was 183 ng/dL. The researchers found lower total and mean testosterone were not significantly associated with lower BMD, nor were longer duration of hypogonadism or higher serum estradiol levels.1 Former or current smoking was associated with a higher prevalence of osteopenia and osteoporosis: 57% of people with osteopenia were former or current smokers, whereas 43% were never-smokers, and the respective numbers for subjects with osteoporosis were 78% and 22%.

The team did not find a correlation between total testosterone levels and t-scores of the spine, hip, or femoral neck. They did find higher total testosterone levels in men who had previously received testosterone treatment than in those who had not received such treatment, but previous testosterone treatment was not associated with higher BMD.1 l

References

1. Sorokin I, et al. Prevalence of bone density deficiencies in men presenting for hypogonadism treatment: do we need to worry? American Society of Andrology’s 39th Annual Meeting, April 4-8, 2014, Atlanta. Poster #69.

2. Dandona P, Rosenberg MT. A practical guide to male hypogonadism in the primary care setting. Int J Clin Pract. 2010;64(6):682-696.

3. The Endocrine Society’s Clinical Guidelines.

Testosterone therapy in adult men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. 2010. http://www.endocrine.org/~/ media/endosociety/Files/Publications/Clinical%20 Practice%20Guidelines/FINAL-Androgens-in-MenStandalone.pdf. Accessed May 6, 2014.

YOUR COMPLIMENTARY SUBSCRIPTION IS ONLY A CLICK AWAY Receive timely information on the latest developments in rheumatology practice Challenges of Starting a New Ancillary Service Piedmont RACTICE MANAGEMENT management to assist you in your Arthritis Clinic: A Conversation with FOR OFFICE ADMINISTRATORS, RHEUMATOLOGISTS, PHYSICIAN ASSISTANTS, PRACTITIONERS daily rolesAND andNURSE responsibilities.

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By Kyle C. Harner, MD, Managing Partner, Carolina Arthritis Center, Greenville, NC

ased on group preferences and patients have limited options for pain state laws, rheumatology physi- control. Because of this, the 3 physicians may or may not write nar- cians in our practice prescribe narcotics cotic prescriptions for patients as part of for patients who we feel need long-term chronic pain management. In Eastern arthritis pain control. We have a protoNorth Carolina, primary care providers col to manage these prescriptions that is seldom write such prescriptions, and in compliance with the North Carolina outside of pain management clinics, Medical Board.

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