Another HCV blow as MSD pulls promotion.

Source: PharmaDispatch 15/04/2019 Author: Paul Cross

The dramatic decline in the uptake of the direct-acting antivirals for hepatitis C has taken another turn with MSD confirming it will no longer promote ZEPATIER (grazoprevir and elbasvir).

According to the PBS Expenditure and Prescriptions report, ZEPATIER was the thirteenth highest cost medicine on the scheme in 2017-18, at $134 million before the payment of rebates.

The company attributed its decision to the dramatic decline in the uptake of the direct-acting antivirals, with treatment rates falling "significantly" in the past year, and "reimbursement pricing caps based on unreasonable patient numbers" and the large and unsustainable rebates.

The utilisation of the therapies first listed on the PBS in March 2016 has fallen dramatically with Hepatitis Australia consistently expressing concern and calling for intervention by the government.

The organisations says the decline in uptake has reached a point where the goal of elimination by 2030 is now not achievable without policy intervention.

Monthly new patient initiations fell below 1,000 in the early months of 2019. Elimination by 2030 requires monthly new patient initiations of 1,500-2,000.

MSD's decision on ZEPATIER is a particular blow given the company's focus on primary care.

A range of key decision-makers, including PBAC chair Professor Andrew Wilson and Commonwealth chief medical officer Professor Brendan Murphy, have highlighted the importance of increased prescribing by general practitioners to the goal of achieving elimination by 2030.

The initial listing of the therapies, in March 2016, was lauded because Australia was one of the first countries in the world to allow prescribing by GPs.

However, while the proportion of the direct-acting antivirals being prescribed by GPs has increased, this is largely because of the dramatic decline in specialists initiating patients on the therapies.

According to Hepatitis Australia, only 10 per cent of GPs are prescribing the therapies, with around 90 per cent having 2-10 patients in their practice that could be diagnosed and cured of hepatitis C.

In a statement to stakeholders, MSD said it will continue to supply ZEPATIER but it will "cease" all promotion of the therapy.

"This includes, and is not limited to sales representative activities, grants, meetings and health care professional sponsorships, advertising and public relations activities, as well as educational activities and events," it said.

In a follow-up response to PharmaDispatch, the company also said, "MSD would like to encourage the Government to do more to encourage GPs to actively screen and treat HCV patients and patients to come forward for treatment. This is required in order for Australia to achieve its elimination goal by 2030."

It continued, "MSDʼs history and commitment to virology; including the treatment of Hepatitis C (HCV) and HIV, spans many years and we are extremely proud of the positive impact we have had on the lives of Australian patients and their families.

"In HCV, MSD has led the way with our primary care strategy giving healthcare professionals and patients choice of cure. This combined with our long-term commitment to specialists has been pivotal in driving towards the 2030 elimination target.

“Despite a rapid uptake of the new HCV treatments over the last three years, the road to eradication in 2030 is facing headwinds. Treatment rates have dramatically fallen, a trend seen in other countries and there are simply not enough patients being screened and treated.

“Although not the primary reason, reimbursement pricing caps based on unreasonable patient numbers and large rebates are unsustainable for companies. This is especially difficult with defined patient populations like HCV and cancers."

The much-lauded pricing deal negotiated by the Australian government essentially means the PBS pays more per patient as treatment rates decline but companies still face the payment of very significant rebates.

Officials have pressured companies in recent months to re-open the pricing agreement while the Department of Health hosted a stakeholder conference call in December last year to discuss the possible simplification of the PBS listings of the direct-acting antivirals.

The participants included medical, patient and research groups, but not the companies with the therapies. Companies were not even informed the meeting had taken place.

“The decision to cease active promotion of our HCV product ZEPATIER was a difficult decision to make," said MSD.

"This decision will not impact any patients currently on ZEPATIER treatment, or any patients seeking future treatment. At MSD, patients are our priority.

"MSD is strongly committed to the ongoing development of innovative medicines to solve unmet medical needs."

Note: This article has been republished with the express permission of PharmaDispatch