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Home » Health, Healthcare Policy, Prostate Cancer

Innovative therapies must be made accessible to all

Submitted by on 30 Mar 2016 – 17:27

Access pathways must foster innovation to address unmet needs, align evidence requirements as treatment options move earlier in the disease course, and remove barriers to access for patients. Jane Griffiths, Group Chairman, Janssen Europe, Middle East and Africa, Janssen Pharmaceutical Companies of Johnson & Johnson writes on enhancing patient access to innovative therapies

Jane Griffiths 2013-136The three million European citizens living with prostate cancer stand to benefit from significant improvements in health as a result of new, targeted medicines. As these innovative treatments become available, access pathways must adjust accordingly by fostering innovation to address unmet needs. Evidence requirements must be aligned as treatment options move earlier in the disease course and barriers to access for patients removed when the value of new interventions is clear.

Innovation must be fostered to meet unmet medical needs in prostate cancer

Innovative, targeted therapies are needed for castration-resistant prostate cancer (CRPC). Research into the genomic alterations present in CRPC has revealed new drug targets as well as novel biomarkers, which present major opportunities for molecular targeting of patient subgroups. New agents have the potential to be effective earlier in the course of disease, slow disease progression and improve health-related quality of life (HRQoL).

Maintaining the pace of pharmaceutical research will require parallel innovation in the approach to regulation and appraisal.

Recommendations:

• Promote early, transparent dialogue among decision-makers and industry throughout the clinical development and life-cycle of medicines, to better identify appropriate regulatory and appraisal requirements.

• Encourage the EU Commission to allocate more funds for research through investment in research centres, advanced databases and patients’ data registries.

Patient access is increasingly fragmented in Europe

Most countries have a formal Health Technology Appraisal (HTA) process to evaluate the clinical (and sometimes cost-) effectiveness and the broader impact of a health technology on patients and the healthcare system. The evaluation is often used to inform pricing and reimbursement decisions and in some countries, to provide prescribing guidance. There is currently a climate where cost is affecting the up-take of new medications. Countries are adding additional hurdles beyond national HTA at the regional and hospital levels, which focus on cost and price. These processes lack transparency, include limited dialogue with industry, and the patient perspective is not explicitly taken into account. Some processes restrict prescribers to a limited use of new therapies and limit the choice of medicines. These additional processes delay or deny access to treatments that would bring the most value to patients and society.

Recommendations:

• If a national HTA assessment considers a medicine value for money, it should be made available to appropriate patients without additional hurdles or unnecessary delays.

• HTA evaluations should be exclusively based on evidence, including real-world evidence and outcomes of particular relevance to patients.

• Collaboration should be encouraged between the pharmaceutical industry, patient groups, physicians, payers, and representatives of the EMA and the EU Health Commission to develop standardised tools for HTA assessment

Surrogate endpoints and patient-reported outcomes are becoming increasingly important

Overall survival (OS) remains the gold standard measure of benefit for regulators. This is most useful in very late-stage disease, as the data will not be affected by patients switching to other effective treatments. As we become better at understanding and diagnosing prostate cancer, and are able to intervene earlier in the course of disease, it may not be realistic to have OS as the gold standard. In pre-metastatic or even local disease, where survival could be up to 10 years, other clinically relevant outcomes, such as overall response rate, progression-free survival, metastasis-free survival and HRQoL should be acknowledged as they offer feasible options to measure clinical benefit.

Recommendations:

• HTA evaluations should include clinically relevant surrogate endpoints that can address a broad definition of value of early disease stages relevant to patients.

• Where OS data are required, HTA should accept adjustments for patients switching drug therapies, and acknowledge the uncertainty of limited long-term data at launch in the evaluation.

The patient voice is not always being heard

Patients live with the consequences of their condition every day, and have their own individual expectations from treatment. Janssen’s recent collaboration with European prostate cancer patient associations on the Prostate Cancer: Living, not Just Surviving survey highlighted the importance of HRQoL issues, with 66% of patients concerned about fatigue and 85% reporting intimacy problems with their partner.

HTA and access discussions should therefore put the patient at the centre of their processes. At present, the degree of patient involvement in national HTA evaluation processes varies by country. For example, patients are not involved formally in France and Italy, whereas England and Scotland have formal processes for patient input. Well-informed patients are vital to this process and Janssen is supporting the efforts of EUPATI to empower patients to engage more effectively in the development and approval of new treatments.

Recommendations:

Prostate cancer patient representatives should be included in all HTA appraisal processes to provide perspectives on the burden of disease and treatment outcomes. Janssen is including patient perspectives in clinical studies and measuring patient outcome in real life. This patient-centric data should be taken into account in HTA evaluation.