MSD Korea applies for reimbursing all 13 indications of Keytruda. Will it lead to a new coverage model?

MSD Korea has recently applied for expanding reimbursement for Keytruda (pembrolizumab) to cover all its 13 cancer indications with high unmet needs.

Among indications newly requested for coverage are triple-negative breast, head and neck, and esophageal cancers, which are aggressive enough to threaten patients' survival, but for which there are no alternatives or newer, reimbursable treatments available, and for which Keytruda is urgently needed to improve access.

While this is great news for cancer patients and healthcare providers faced with reimbursement barriers, it is a headache for the government as it will require a huge financial outlay.

As the frontrunner among immunotherapies, Keytruda is also facing a conundrum in determining insurance benefits. That’s because the drug is expensive, but the indications are growing. Recently, it has evolved into an anticancer drug based on biomarkers regardless of cancer type, requiring a change in the domestic reimbursement review frame centering around specific cancer types.

Pharma firms with cancer drugs with indications across multiple cancers, like Keytruda, are watching the government's negotiations with MSD with a mixture of concern and anticipation. If MSD successfully bargains, they must consider introducing a new reimbursement track.

Against this backdrop, Korea Biomedical Review met with Kang Sook-hyung, a managing director and head of the Market Access (MA) team at MSD Korea, to learn more about the background of Keytruda's lump-sum coverage application, its reimbursement strategy, and its approach to negotiating with the government.

Managing Director Kang has over 20 years of experience in the pharma industry. She started working in pharmaceutical pricing in 2010 and has extensive experience in economic feasibility studies as a doctor of social pharmacy. She has been with MSD for 14 years, including two years as the regional head of Asia-Pacific, supporting countries with their HTA (Health Technology Assessment) submissions. She has since returned to Korea to lead the MA team.

Question: What exactly does the MA team do?

Answer: The MA team builds a bridge between the company and the government to ensure that products reach patients through the market. It is responsible for managing and reviewing the entire lifecycle of a drug, including pricing, reimbursement, and overall patient access. Therefore, the MA team starts by evaluating the characteristics and value of a product even before it is licensed.

In the past, the focus was on pushing medicines into the reimbursement sphere of the public insurance system. More recently, however, the team has been racking its brain to increase patient access. We want to make the best treatment options available to as many patients as possible and, ultimately, to all patients.

To that end, we work with the government to constantly review existing regulations, rules, and other areas that need to be improved, as well as to consider new options and make policy recommendations. MA's work is always dynamic, as there are many issues that the government and companies need to solve together. However, as difficult as these problems are, it is very rewarding when they are finally solved.

Q: How do you assess the government's current drug benefit policy?

A: In recent years, there have been more communication channels with the government, including public-private deliberation bodies. As communication channels have increased, the time to see the results has been a little advanced. It's great to see that ultra-high-priced drugs are being covered rapidly and that the government is interested in and closely involved in diseases and drugs with high patient demand and is trying to find solutions ultimately.

The policy is an area bound to follow technological advances. Companies bring in drugs, weigh their value, and submit proposals for health insurance coverage based on that, and governments decide whether they can afford it or not and devise a plan to accommodate it. As one of the Korean people, rather than a head of the MA team, I support the government in fulfilling its role.

Q: In June, Keytruda drew the industry’s attention by applying for a lump-sum reimbursement for its 13 indications. Was there a particular reason for this unusual move?

A: The team had endless discussions before we decided to apply for the coverage of 13 different cancers. We reviewed a lot of data while discussing with multiple related departments, including marketing and medical affairs. During such discussions, we looked at various factors, including medical factors, and thought long and hard before coming to a consensus. In the end, the consensus was, "Let's do our best to provide a reimbursement opportunity for all patients who need treatment with Keytruda.” We began the process with the efforts of the MA team and many other people.

I don't know of any other case where a single drug has demonstrated efficacy in so many cancer types (indications). The decision was possible because it was for “Keytruda.” We look forward to the day when all cancer patients who can benefit from Keytruda will have the opportunity to live longer and better lives as a result of this decision.

Q: Were there no fears that such an attempt might fail?

A: I think Keytruda is a drug about which we can do nothing if we focus on its practicability. So, our discussions focused more on "finding a direction" than feasibility. We agreed, saying, "Okay. Let's make it happen." Behind such a decision were a lot of healthcare providers and patients interested in expanding access to Keytruda. MSD Korea had too much of a responsibility to apply for only indications with a high likelihood for reimbursement, so we made a bold challenge, considering all these factors.

Q: Have you had preliminary talks with HIRA about the bulk application?

A: During the preliminary consultation, the Health Insurance Review and Assessment Service (HIRA) offered us a brief opinion, but the committee made the final decision, so it is difficult to predict the outcome based on that alone. We will have to solve each problem individually through the review process. However, HIRA has experts who have much experience in drug management. If we work together, we will produce a good result.

Expanding reimbursement is a decision of the health authorities, so it's hard for us to speculate at this point. We will continue to work closely with the health authorities and healthcare providers to make progress toward one goal -- save lives and improve the quality of life for more Korean cancer patients through increased access to Keytruda.

Q: We were wondering whether MSD Korea has proposed a new program to the government in applying for this reimbursement.

A: Other countries currently use indication-specific or weighted average pricing among indications. Since Keytruda has many approved indications and proven clinical value and innovation, some countries are shifting to a review that focuses more on managing the financial impact of Keytruda as a whole rather than evaluating the clinical value of individual indications. For example, they are simplifying or waiving economic evaluations and setting tiered total and reimbursement rates based on usage, considering indications to be approved in the future.

Internally, we have also thought much about how to expedite coverage for many of Keytruda's indications and how to ensure the health insurance’s finance. Given the characteristics of immunotherapies, I am cautiously optimistic that the company can find a sufficiently Korean "customized model" if it actively engages in head-to-head discussions with the government.

Q: Lastly, how do you feel about beginning negotiation for Keytruda’s reimbursement?

A: I've been involved with Keytruda since its inception, so it's a drug to which I have a strong connection. My child was born in 2017, and Keytruda was first on the registrar in 2017 as a second-line treatment for non-small cell lung cancer (NSCLC). So watching Keytruda grow - the way it's become more accessible to patients and widely used - feels like watching my child grow. I'm proud to see more patients benefit from Keytruda, and I'm grateful to be a part of it.

I'll also never forget Keytruda’s expanded reimbursement as primary NSCLC. I still remember the words of a National Health Insurance Service (NHIS) manager on the last day of negotiations. "With the conclusion of this negotiation, 5,000 lung cancer patients in Korea will be covered by insurance. Over the past four-and-a-half years, MSD Korea has done the same, and the NHIS has used all its resources to finalize the deal. It was a win-win situation for both sides," the manager said. On the occasion of that remark, I believe we are now trying again to expand coverage for Keytruda for 13 other cancers.

Governments and pharmaceutical companies have a common goal: to create a better patient treatment environment.

Despite our differences, we are partners in increasing patient access to good medicines. It will be challenging, but we can reach a common goal through an active consultation. To this end, we are ready to discuss with the government transparently and with an open mind. If the government is open-minded and willing to find a way forward, we hope that the drugs that many cancer patients and healthcare providers are waiting for will soon be available as a benefit option in Korea.

The MA team is looking forward to that day and is working hard to speed it up. We also hope to find a customized Korean reimbursement model for immunotherapy drugs.