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Oral cancer drugs can offer a more convenient alternative to traditional IV therapies when it comes to treating patients, but issues such as adherence and reimbursement still need to be ironed out, while payers have to be convinced that oral agents represent value for money.

By Adam Hill on Feb 2, 2015

The cancer landscape is changing

Receiving a cancer diagnosis is a life-changing event but in recent years, steadily declining per-capita incidence and progressively growing survival rates have brought some encouragement for patients. A widening range of treatment options including surgery, radiation and conventional infused chemotherapies is largely responsible for the good news that fewer people are contracting the disease and those who do are living longer - but this creates a situation where, rather than being treated for a couple of months after this de facto death sentence, more and more patients face lengthy medication regimes. These survival rates, coupled with ongoing breakthroughs in several classes of oncology drugs, continue to provide strong market growth opportunities – but also knotty problems - for drug developers.

Getting adherence right

One burgeoning area of pharmaceutical interest is oral oncolytics, which give patients the freedom to receive cancer treatments at home – in pill or capsule form, as opposed to via traditional intravenous (IV) infusion in a clinical setting. Oral Therapies in the Oncology Marketplace, a briefing paper from eyeforpharma, surveys this changing landscape and turns the spotlight on the key issues for manufacturers. The analysis of the numbers reveals that 70-80% of US drug spend in cancers is still related to infused products.The oral option means patients no longer have to spend six hours plugged in to a drip - they can instead self-medicate in privacy and comfort, perhaps continuing even to work throughout their treatment if they can. However, there are also significant downsides: self-administration of powerful toxic therapies in an unsupervised home setting can lead to sub-optimal drug adherence and poor management of side effects, and potential adverse reactions and unintended drug interactions. In order to work, the system requires patients to be organized, but in fact they are often – through no fault of their own - unreliable, disorganized and non-health literate. The potential wastage due to premature drug discontinuations is significant. While serious, all of this is not going to be enough to derail the march of oral oncolytics – but it does mean that stakeholders have to work to rectify what is a huge challenge.

Complexities of reimbursement

Adherence is not the only issue: intertwined with the problem of adherence are the unusual reimbursement considerations associated with oral oncolytics, which often create significant additional out-of-pocket cost burdens for patients, explains Michael Kolodziej, National Medical Director forOncology Solution at Aetna. Behind closed doors, some industry experts even refer to the “financial toxicity” of the new treatments. Pills are typically covered under patients’ pharmacy benefit (or MedicarePart D). When it comes to reimbursement, most are placed on tiered specialty formulary designations that require higher out-of-pocket co-pays, and in some cases co-insurance, from patients. This higher financial burden impacts both access and utilization, leading to early drug abandonment, which in turn has a direct impact on health outcomes: the prescriber will not know whether the drug actually works, the payer is footing the bill for a treatment which was not given the chance to succeed, and the manufacturer sees its brand suffer – leading to (possibly unwarranted) scrutiny from investors and regulators. The ripple effect in this interdependent economy is complex. Based on in-depth interviews with executives in the industry and stakeholders in managed care, the paper takes a clear-eyed look at the challenges and potential benefits of sending patients home to self-administer often complex therapies – which amounts to a “leap of faith”, according to Burt Zweigenhaft, Vice Chairman, Onco360 Oncology Pharmacy.

Possible solutions

Hub-support is far more than just a buzzword: a recent initiative by LashGroup for a manufacturer of one oral oncology agent drove a 40% increase in the amount of time patients stay on therapy".

Part of the solution might be to invest in hub-support services which seek to anticipate patients’ needs. Hub-support is far more than just a buzzword: a recent initiative by LashGroup for a manufacturer of one oral oncology agent drove a 40% increase in the amount of time patients stay on therapy. Such best-in-class programs not only benefit patients by driving better clinical outcomes, but can help practices and garner support from payers, allowing doctors to make the case for better care and case management. To address financial issues, drug makers are also widely offering co-pay assistance cards and discount coupons, which help offset some of the expenses for patients. While these mechanisms for financial support have not historically been offered for oncology drugs, many companies today are doing so in exchange for preferred designation on formulary, says Dana Evans, Director, Quality of Care and Patient Access, US Medical Affairs at Genentech. In order to mitigate concerns over the high price of new oral medications, and to hence achieve more favorable formulary status – drug makers are also increasingly offering a variety of discounts and rebates that benefit payers too. They might, for instance, provide the first month of therapy for free as part of bridging programs, a strategy which can also eliminate potential delays in treatment initiation of up to two weeks experienced by some patients while drugs are being approved by insurers for reimbursement, notes Manuel Duenas, Director, Global Oncology Pricing and Market Access of Gilead Sciences.

The use of data

The ability to quantify potential cost savings associated with using oral therapy in terms of reduced hospitalizations and emergency room admissions will help to shift the focus with key opinion leaders".

However, the hard reality is that if evidence for the use of certain drugs for specific patients is lacking and there is no proof of impact on survival, then payers cannot be expected to keep covering the bills – especially as the number of people living with cancer for longer continues to climb, warns Zweigenhaft. Putting together a case that is based around more than the cost of the drug itself is becoming increasingly important. To achieve the most favorable formulary designation and maximize patient access, pharma companies need to find ways to develop and present pharmacoeconomic data which illustrate the full value of their therapies. The ability to quantify potential cost savings associated with using oral therapy in terms of reduced hospitalizations and emergency room admissions will help to shift the focus with key opinion leaders (KOLs). The idea of lowering costs for the overall treatment option is persuasive.

The future of the “oral option”

The paper advices industry not to  ignore non-oral cancer drug options, and provides a balanced look at other novel treatments and promising advances with monoclonal antibodies and antibody-drug conjugates. The analysis indicates that IV oncolytics will maintain a strong market position alongside oral alternatives. It’sclear that the oral option is welcomed by the healthcare eco-system because of its immense benefits for patients in terms of their convenience and wellbeing. It can also be cheaper than carrying out treatment in a medical setting – as long as the patient gets it right and reimbursement issues can be addressed. The paper suggests that, in the industry, ongoing support for developing oral cancer medications remains firm given the upside to the equation. Everyone has a keen interest in making it work: cancer patients, the medical community and drug developers have to work together to identify best practices related to the treatment of cancer. The challenges around the commercialization of oral oncolytics illustrate that it will indeed require a collaborative effort to overcome clinical, financial, physicaland psycho-social barriers, so that any given patient’s cancer can be affordably treated as an ongoing, chronic condition. The rewards are there for all.

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Oncology Market Access & Pricing will take place 15-16 June in Boston. For more information on the event, click here.