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I’ve been seething since I read Prime Therapeutics’ October 17 news release asserting that patients are being prescribed biologics outside of American College of Rheumatology (ACR) guidelines. The referenced Prime Therapeutic reports assert that patients are being switched from conventional DMARDs to more-expensive biologic treatments before the DMARD therapy is given a proper chance to work (as much as 24 weeks – or almost six months). The report concludes this has caused an unwarranted higher total cost of care for RA patients. The conventional first-line DMARD is methotrexate (MTX) and the triple therapy of MTX/hydroxycholoquine/sulfasalazine was also discussed.

For those of you who are not familiar with Prime Therapeutics, they manage pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. Their opinions affect more than 20 million people. For many, this is the entity that determines whether or not their prescribed medication treatments are approved and whether there are pre-approvals or step-therapies involved.

I get it. Someone needs to keep an eye on keeping prescription costs in line. But focusing solely on the cost/benefit ratio excludes the patient’s best interests from the equation. Even the National Institute of Health (NIH) has stated, “The treatment of RA has been transformed in the last decade with the introduction of several targeted biologic agents. Although biologic agents are more costly in the short term than conventional disease-modifying antirheumatic drugs, drug-specific costs may be offset by significant improvements in RA symptoms, slowed disease progression, and improved physical function and quality of life for patients.”

I could spend pages taking Prime’s conclusions to task, but I will limit my comments to four major points:

  1. While the report tracked when patients were switched to a biologic, the reasons why the patients were switched were not included. By excluding this data, the report appears to imply that switching from conventional DMARD therapy was done without medical merit. This is not necessarily true. For example, there are patients who have concerning side effects from MTX including liver toxicity. There are other valid medical reasons for switching from MTX including other drug interactions and patient compliance issues.
  2. Physicians are the best judge of which drugs will be the most effective for their patients. They see the living results of treatment plans every day in their practice and they have front-line knowledge of which medications are the best choices for their patients based on a number of variable factors. As an example, not all patients are diagnosed in the early/mild stages of the disease. In fact, many are misdiagnosed for an extended time and, by the time the rheumatologist sees them, may have developed an aggressive/severe disease state. It should be the physician’s call as to whether conventional DMARD therapy is the best choice or whether more powerful biologics are needed. A simile to Prime Therapeutics report would be if your house was on fire and when you called 9-1-1 they said you must try a fire extinguisher first because it cost the city a lot of money to send out a fire brigade.
  3. Patients are financially involved in these decisions. Yes, RA drugs are some of the most expensive drugs there are, but companies such as Prime seem to forget that patients share in paying for these drugs. Either the drugs aren’t covered at all, have only a percentage of the cost covered or the patient’s coverage has high deductibles and/or copay amounts. Patients have as much or more motivation to control health care costs as companies such as Prime. I recently met an RA patient who had to make the choice of paying for her RA treatment or pay for college to finish her degree. These kinds of personal sacrifices are not unusual and underscore the importance that patients put on finding an effective treatment.
  4. Some of the information in the Prime Therapeutics’ news release is suspect. For example, there is a quote in the Prime Therapeutics’ news release that starts, “RA guidelines supporting use of conventional DMARDs before biologics have been in place for more than two decades …” This is an interesting statement given that the first biologic, Enbrel, wasn’t introduced until 1998, less than two decades ago. In addition, both the NIH and the ACR both reference the ACR’s 2008 recommendations for the use of nonbiologic and biologic DMARDs in RA (published less than one decade ago). These recommendations clearly state that the ACR, “… has not previously developed recommendations for recommendations for biologic agents.” The ACR updated these recommendations in 2012, which was five years ago (not two decades). The latest ACR guidelines are from 2015 and cover the overall treatment of RA, including the use of biologic and nonbiologic DMARDs. I’m not sure where the Prime Therapeutics got their two decades of recommendations. True, they may be referencing some other, less-prominent guidelines but in the US the ACR is the defining authority. And if they did actually get this statement incorrect, it makes you wonder what else is incorrect in their information.

I actually read the ACR’s 2015 Guideline for the Treatment of RA and, as much as I searched, I couldn’t find any reference to how long a patient should be on “conventional DMARD” treatment before being transitioned to a biologic. In fact, contrary to Prime Therapeutics assertion that switching between conventional DMARDs and biologics is contrary to the ACR guidelines, the ACR recommendations clearly state the following:

This RA guideline should serve as a tool for clinicians and patients (our two target audiences) for pharmacologic treatment decisions in commonly encountered clinical situations. These recommendations are not prescriptive, and the treatment decisions should be made by physicians and patients through a shared decision-making process taking into account patients’ values, preferences, and comorbidities. These recommendations should not be used to limit or deny access to therapies.

I am in favor of controlling prescription costs. I also strongly believe that controlling costs should not interfere with practicing medicine or with prescribing appropriate treatment plans for a patient. Unfortunately, the influence that Prime Therapeutics wields has the ability to do just that.

Thanks for checking in.