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A Look at Drug Cost, Financial Assistance Opportunities

Issue: October 2014

ByLeah Molloy, PharmD

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New direct-acting antiviral drugs have been widely embraced as more effective and less toxic treatment options for patients with hepatitis C virus. Besides the drugs’ clinical merits, including high efficacy, tolerability and ease of administration, the cost of therapy has gained significant attention from mass media and patient advocacy groups, along with clinicians and patients.

Leah Molloy

The introduction of new high-cost medications for HCV prompts comparison to other expensive drugs such as eculizumab (Soliris, Alexion Pharmaceuticals), which is priced at approximately $6,000 for a single vial, and ivacaftor (Kalydeco, Vertex Pharmaceuticals), which is priced at approximately $15,000 per month. Using the two most recently approved DAAs as examples, sofosbuvir (Sovaldi, Gilead) has been priced at $84,000 for a 12-week treatment course and simeprevir (Olysio, Janssen Therapeutics) has been priced at $66,000 for a treatment course.

An important difference between the DAAs and other expensive drugs is the number of patients projected to receive the therapies. Eculizumab is indicated for two very rare genetic diseases, each of which affects only one to five patients per 1 million people. Ivacaftor is effective for only about 5% of patients with cystic fibrosis. By comparison, HCV is a much more prevalent disease, with an estimated 3 million to 4 million people infected in the United States alone. Thus, the high costs of new HCV therapies is making a substantially greater impact on health care expenditures than other very therapeutic agents largely directed against orphan disease states.

Problematic Pricing

The high cost of new HCV therapies has become a target of public scrutiny, but some very low prices have caught widespread attention as well. Namely, the cost of sofosbuvir in Egypt, where the prevalence of HCV is the highest in the world. Patients in Egypt with HCV are able to receive a full treatment course for $900, which translates to a 99% cost reduction compared with the United States. This financial reflection of Gilead’s commitment to ensure sofosbuvir access to patients in Egypt has not been well received by some patients and policymakers in the United States. In mid-September, Gilead announced that it signed licensing agreements to allow seven pharmaceutical manufacturers in India to produce generic versions of sofosbuvir to treat patients with HCV. Under the agreements, the licensees can set their own prices for their generic offerings of the drug, paying a portion of sales to the company for business support of product registrations, medical education, and training and safety monitoring. The licenses also permit the manufacture of the investigational single-tablet sofosbuvir/ledipasvir combination, according to a press release.

It was recently announced that the pricing of sofosbuvir may increase Medicare spending by more than $5 billion. In July, the US Senate Committee on Finance issued a letter to Gilead requesting financial information, including how the price was determined, expected changes to promotional spending and drug price in coming years, an analysis of financial relationships between Gilead and key professional societies, and details of the patient assistance program.

Clinical trials and advice from HCV experts also have been called into question as payer groups struggle to understand and respond to clinical appropriateness and financial impacts of treatment recommendations, should they be embraced nationwide.

Another topic of discussion is the joint HCV treatment guidance from the American Association for the Study of Liver Diseases (AASLD) and the Infectious Diseases Society of America (IDSA), in collaboration with the International Antiviral Society-USA (IAS-USA), which was developed and is maintained online as a means to provide timely guidance to practitioners in this rapidly evolving field. The guidance acknowledges a lack of access to medications secondary to high cost as a barrier to treatment and suggests participation in manufacturer assistance programs and expansion of prescription cost coverage. The guidance also provides recommendations for treatment, recommending sofosbuvir-based regimens for essentially all treatment-naive and relapsed patients with HCV genotypes 1 through 6, regardless of previous treatment attempts or lack thereof.

Cost of Cure

Given conflicting advice from government analysts and clinical experts and pending a response from Gilead to the US Senate request for pricing information, several cost-effectiveness analyses have been conducted.

Petta and colleagues assessed the cost effectiveness of sofosbuvir-based triple therapy as compared with boceprevir- and telaprevir-based triple therapy in untreated patients with chronic HCV genotype 1 according to IL28B genotype, liver fibrosis and genotype 1 subtype. According to the results, sofosbuvir was cost effective for some patients, including those with IL28B CC/TT and genotype 1a, but not cost effective for others, including those with IL28B CC, fibrosis F0-F3 and cirrhosis. The researchers concluded in Hepatology that sofosbuvir-based triple therapy may be a cost-effective alternative to first-generation inhibitors, depending on pricing.

In another study, Saab and colleagues factored in anticipated costs and mortality associated with liver transplants and the expectation of significantly fewer liver transplants among patients receiving sofosbuvir (17 transplants per 10,000 treated patients vs. 40 to 68 transplants per 10,000 treated patients with other regimens) to find sofosbuvir-based triple therapy less costly and more effective than triple therapy with any of simeprevir, boceprevir and telaprevir for the treatment of patients with HCV genotype 1.

Patient Financial Assistance Opportunities

A number of payment assistance programs have been developed to help patients pay for their HCV treatment courses and are available through manufacturers, government and charitable foundations. Although important exclusion criteria such as full or partial government payment assistance and household income restrictions exist, there are a considerable variety of options (see Table). However, an analysis co-authored by the Kaiser Family Foundation’s Directors on Medicare Policy and a PhD health policy analyst warns that patients covered by Medicare Part D can still expect significant out-of-pocket expenses, up to $7,000.

As more HCV drugs in the pipeline are expected to gain FDA approval, competition between manufacturers is anticipated to drive down some costs. Also, because the newer DAAs were approved in late 2013, prescription drug payment assistance programs were unprepared for the impact that would be made on the 2014 budgets. For future years, these expensive therapies can be factored in to annual premium bids.

Just as novel DAAs represent an unprecedented breakthrough in the treatment of a significant public health issue, they bring with them a similarly unprecedented combination of concerns and varied practices regarding who and when to treat with which therapies.