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Meds For My Pump: Common Medication Insurance Encounters in MCS


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Jennifer Day, PharmD
Baptist Health Transplant & VAD Institute
Little Rock, AR, USA
Jennifer.l.day@baptist-health.org



As insurance companies continue to increase the regulation of health plan formularies, in an attempt to control costs, the use of any 'off-label' medication therapies is under scrutiny like never before. As practitioners who care for such a unique patient population, we frequently encounter the use of newly approved or investigational devices. We are familiar with the medical management of complex patients with countless co-morbidities. Not unexpectedly then, we sometimes find it beneficial to use even "old" drugs in new ways or for indications not yet approved by the FDA. I'll highlight a couple of my favorites from experience in our VAD clinic.

Dipyridamole initially received approval by the FDA in 1961 for use in the treatment of angina and later in 1986 as an anti-platelet agent [1]. Although it had largely fallen out of fashion, dipyridamole has found resurgence as part of the anticoagulation regimen recommended for patients implanted with many of the current left ventricular assist devices (LVADs). Though numerous publications now describe and support the use of dipyridamole in this patient population, it continues to require prior authorization and non-formulary exception from numerous health plans for coverage. Thankfully, the process in this instance is usually straightforward and authorization is generally achieved with the first request. Being able to attach device specific literature and clinical guidelines available on the FDA's website to support the request is of great benefit [2].

Another prior authorization request that keeps popping up (pun intended) on my desk is one for sildenafil. As we know, the phosphodiesterase type 5A inhibitors have been shown repeatedly to help decrease pulmonary vascular resistance (PVR) in patients with persistent pulmonary hypertension (PH) following LVAD placement [3]. However, sildenafil is currently only FDA approved for use in the treatment of patients with WHO Group I, to improve exercise ability and delay clinical worsening [4]. Getting insurance authorization for its use in our WHO Group 2 patients (PH due to left heart disease) generally requires more effort. Some insurance plans will require pulmonary pressure readings from cardiac catheterizations while others will accept detailed ECHO transcriptions. Some have hard stops for approval with specified parameters for pulmonary arterial pressures, pulmonary capillary wedge pressures, and pulmonary vascular resistance. Others will not authorize coverage for any indication other than the approved WHO Group I. Often the process entails filing an initial request for authorization of coverage, waiting for a denial, filing for an appeal, waiting for another response, and sometimes then results in a review by a third party or a peer-to-peer request. Any less persistent practitioner might recant at some point during that exhausting process (which may very well be the intent). But when therapy is truly indicated, the process cannot be avoided.

The effort and time spent obtaining necessary authorizations for coverage can be burdensome to an already overworked clinical staff. The process, sometimes unresolved after days of faxes or electronic appeals back and forth, can leave patients to pay out of pocket for new medications in order to avoid lapses in therapy. We can all agree that regulations are absolutely necessary to safeguard against inappropriate medication use. In addition, we must be mindful of drug related costs and choose less expensive alternatives when clinically appropriate. However, our ability to thoughtfully prescribe medications cannot be compromised; even when the proposed indication is 'off-label' or there are no large, randomized controlled trials available to support us. Given the processes by which coverage for these medications are obtained, it is imperative that authorization paperwork is started in advance to maximize the access that patients can have to these beneficial therapies. Additionally, being proactive in gathering information that is required upfront by insurance payers can help expedite these issues. Engaging your financial coordinators and case management professionals can assist in this process.

Our unique patient population will continue to challenge conventional medication management and require creative solutions. However, if the innovative use of medicine that has brought us to our present practice becomes stifled by rigid inclusion criteria that disregard clinical reasoning, then hope for future advancements and gains will be lost. We must continue to collaborate as medical professionals practicing in this specialty. We must share information and experiences by contributing to the medical literature in the form of case reports and commentaries, sharing questions and answers on list serves, gathering for formal meetings, and working together to create consensus guidelines for care based on our collective expertise. At the end of the day, no matter how cumbersome, we must continue the task of advocating that our health care industry cover such beneficial and reasonable therapies for our patients. By working together, we can increase the strength of our appeals, decrease denials of coverage, and continue to improve patient access to the cutting edge, life-saving therapies we have to offer. ■

Disclosure Statement: The author has no conflicts of interest to disclose.


References:

  1. Dipyridamole: Description/Classification." Clinical Pharmacology. Updated 13 July 2015. Web. Accessed 18 August 2016.
  2. Russell S, Slaughter M, Pagani F et al. HeartMate® II LVAS: Patient Management Guidelines. www.FDA.gov. Revision O. 14 Dec 2006. P. 34 - 36.
  3. Tedford R, Hemnes A, Russell S et al. PDE5A Inhibitor Treatment of Persistant Pulmonary Hypertension After Mechanical Circulatory Support. Circ Heart Failure 2008;1:213-219.
  4. Revatio [package insert]. Pfizer Inc., New York, NY; 2014. Revised 2015.



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