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Hep C Drugs in 2016: More Combos and Lower Cost

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While some exciting new drug combos are on the approval horizon, cost concerns will drive interest in Hepatitis C treatment for 2016.

Hepatitis C treatment has improved dramatically in the past few years. More than ever before, eliminating the Hepatitis C virus from the bloodstream is now accompanied by favorable odds. Efforts to eradicate this virus have been steadily gaining momentum, as the pharmaceutical industry has made Hepatitis C drug development a priority. In 2016, we anticipate this trend will continue. Newer, safer, more effective and more affordable treatments are expected to emerge, besting the progress made in 2015.

Progress

Hepatitis C drug progress over the past three years is impressive:

  • In 2012, the standard of care for Hepatitis C infection was combination treatment with pegylated interferon and ribavirin; a regimen that lasted about six months, was associated with severe side effects and was only about 50 percent effective.
  • In 2015, the standard of care was Harvoni (sofosbuvir and ledipasvir), Viekira-Pak and ribavirin, Daklinza and Sovaldi, or Olysio and Sovaldi for three months – and is between 80 and 95 percent effective.

Unfortunately, all of the medications that constitute the standard of care in 2015 are prohibitively priced in the U.S. A three-month course of Hepatitis C treatment typically runs between $80,000 and $120,000. The cost of the drugs set the stage for a battle between patients and health insurers.

The Price War

Because of the steep prices, many insurance companies and state Medicaid programs will only authorize treatment for those who have the most advanced stages of liver disease. These policies restrict Hepatitis C medications to those with advanced fibrosis, cirrhosis or other extrahepatic manifestations. According to Andrew Aronsohn, MD, assistant professor of medicine at The University of Chicago and an expert on hepatitis treatment, “Really curing Hepatitis C is now within reach for a majority of the patients that we see. The big issue revolves around cost and access to care.”

Two positives that emerged from this Hepatitis C drug price gouging were:

  1. Towards the end of 2015, the Centers for Medicare and Medicaid Services issued a notice to state Medicaid programs that they were breaking the law and should lift the restrictions placed on access to Hepatitis C medications.
  2. Insurance company denials to cover Hepatitis C treatment led to many lawsuits in 2015. Although no judgments have been entered yet, 2016 could set a precedent requiring insurers to pay.

These high prices mostly impact seemingly wealthier countries, like the U.S. However, some of the highly effective Hepatitis C drugs are available elsewhere at a fraction of the cost. Analysts estimate Hepatitis C treatment in chosen locations with access to the generic versions range from $200 to $900. Gilead has licensed sofosbuvir and ledipasvir to some countries (India, Pakistan and Egypt) to make a generic version. In addition, some countries are able to produce Daclatasvir as a generic drug. Because they are much less expensive, experts believe that allowing Hepatitis C medications to be generic is one of the most important strategies for eliminating Hepatitis C worldwide.

Two New Combos

New, effective drugs entering the Hepatitis C marketplace will also cause the cost of the current treatments to drop. Two drug combinations with reportedly high success rates are very close to FDA (US Food and Drug Administration) approval.

  1. At the end of January 2016, Merck’s combination of elbasvir and grazoprevir is expected to earn FDA approval. The brand name of this drug is Zepatier and trials demonstrate cure rates of up to 99 percent in genotypes 1, 4 and 6.
  2. Gilead’s sofosbuvir plus velpatasvir have completed Phase 3 trials and have posted cure rates of 97 to 100 percent in genotypes 1 through 6. This combination is expected to be FDA approved in 2016. Sofosbuvir plus velpatasvir is encouraging for all genotypes but especially genotype 3 with cirrhosis, where the cure rate was 91 percent.

Knowing that Merck and Gilead both have new Hepatitis C treatment regimens likely to be approved, the outlook for conquering this virus is great. In addition, pressure to reduce the treatment cost is expanding. Hopefully, 2016 will host the decline of Hepatitis C treatment prices in the U.S. If not, we are likely to witness Americans taking treatment vacations to countries that have been able to secure generic versions of the current Hepatitis C medications.

http://hivandhepatitis.com/hcv-policy-advocacy/5522-sofosbuvirdaclatasvir-combination-could-be-produced-for-200-per-hepatitis-c-cure, Sofosbuvir/Daclatasvir Combination Could Be Produced for $200 per Hepatitis C Cure, Keith Alcom, Retrieved January 3, 2016, HIVandHepatitis.com, 2016.

http://hcvadvocate.org/news/NewsUpdates_pdf/Advocate_2016/advocate0116.pdf, Happy New Year! – Top News 2015, Alan Franciscus, Retrieved January 3, 2016, Hepatitis C Support Project, 2016.

http://www.everydayhealth.com/news/pros-cons-new-hepatitis-treatments-patients/, Pros and Cons of New Hepatitis C Drugs, Anne Harding, Retrieved January 3, 2016, Everyday Health Media, LLC, 2016.

http://www.hepmag.com/articles/2512_18756.shtml, Hepatitis C Treatment-Naïve Recommendations, Retrieved January 3, 2016, Smart + Strong, 2016.

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