Differentiated medicare: Say no to ‘one size fits all’

April 19, 2011

April 2011

People are different and no single treatment suits two different patients despite the presence of same symptoms. This has prompted clinicians and drug manufacturers to move towards providing medication specific to particular patient populations, that is personalised healthcare.

Personalised Healthcare (PHC) is about providing treatment as per patients’ needs for obtaining better clinical outcomes. It is based on the concept that the treatment will be selected based on patient characteristics that are identified through molecular diagnostic tests.

PHC recognises that all individuals are different and that the ‘one size fits all’ approach is not effective. While a drug can be highly effective for one patient, the same might not show the desired results when given to another patient with the same diagnosis.

Experts today are able to tailor treatments according to the needs of specific patient populations based on the knowledge of biology, diseases, mechanisms of action of drugs and the biological differences between patients as well as the characteristics of their disease. This has helped in making healthcare better, safer and more cost-effective.

PHC is a key enabler for further improvements in medicine. This will enhance the safety and efficacy of medicines as well as improve patients’ lives, their health, quality of life and survival. Therefore, the prime objective here is to provide PHC solutions, which deliver superior options for diagnosis and treatment to clinicians and patients.

Pioneering PHC

PHC is not a new concept. There are a number of excellent examples of successful implementation of PHC in medical practice, and numerous PHC solutions are also available today. However, in recent years, the considerably increasing knowledge of the human body and disease mechanisms has helped in concluding that PHC approach will soon become important. The goal is to provide healthcare professionals with more powerful diagnostic tools and with targeted treatments based on new insights, at the molecular level, about how diseases arise. PHC is a win-win situation for everybody involved, ie, regulators and policy makers, industry, payers and reimbursers, physicians and providers and, most importantly, patients.

For patients, it means better treatment outcomes with safer and more cost-effective treatments,
For regulators and policy makers, it means increased efficacy and safety as well as reduced healthcare costs
For industry, it means differentiated medicines and new diagnostic tests
For payers and reimbursers, it leads to an efficient use of healthcare budgets and increased cost benefit per patient
For physicians and providers, it means obtaining maximum benefit with least toxicity.

Today, one in three medicine fails to produce the desired effect, and only about two-thirds of all patients actually benefit from their drug treatment. In fact, one in seven or eight patients actually feel worse after treatment than before. This situation is not particularly satisfactory.It is unsatisfactory for patients or doctors because neither the desired effects nor side effects can be clearly defined or reliably calculated. Also, it is unsatisfactory for health insurers because they have to pay for treatments, the quality of which leaves a lot to be desired in several cases.

This gave rise to the concept of PHC, where the treatment is tailored to specific needs of individual patient groups. This new approach to healthcare is facilitated by progress in the field of molecular diagnostics tools, which has been fuelled by identification of new biomarkers, and thereby increasingly favoured by the stakeholders in the healthcare system. This could perhaps be described as a quantum leap in drug therapy. The relationships between drug response and individual genetic variations called pharmacogenetics provide information that when considered with other factors, helps physicians to better assess the right medication dosage for a patient.

People are different, but drugs are not differentiated enough. There is a great need for more effective and safer medicines. PHC should not be (mis)interpreted as that every person receives medicines made just for them. Rather, it expresses the idea that groups of individuals with shared features – eg, genetic characteristics – can be ‘bundled together’ such that treatments can be optimally tailored to their needs.

On an average, 20-80 per cent of patients actually profit from the medicines they take. This is because today’s medicines are generally standardised products meant for general patient population – PHC, however, strives to differentiate.

Any course of treatment starts with a diagnosis, ie, identifying the patient’s illness as accurately as possible. The more accurate the diagnosis, the more successful drug therapy is likely to be. Here, Roche is in an excellent position since it is the only healthcare company in the world to possess top-class-in-house expertise in both areas. As such, we are extremely well placed to provide ‘custom-made treatments’ that are perfectly suited to patients. With the pillars of diagnostics and pharmaceuticals, the Roche Group is perfectly positioned to pursue the goal of PHC, and over the last few years, has shown examples of how interweaving diagnostic and pharmaceutical expertise pave the way to achieve this goal. Roche’s portfolio encompasses the fields of oncology, virology, metabolism, transplantation and many more, as explained hereafter.

Oncology

Breast cancer: One of the greatest advancements in the treatment of breast cancer is the drug, Herceptin, which targets Human Epidermal growth factor Receptor 2 (HER2)-positive breast cancer, a type of more aggressive breast cancer. However, not every patient responds to this treatment in the same way. Approximately 25 per cent of breast cancer patients have HER2 gene over-expression. By measuring the presence of the growth factor, HER2, in breast cancer through a specific HER2 test supplied by Roche Tissue Diagnostics (Ventana), it is possible to determine HER2-positive beast cancer patients who will respond to Herceptin.

Colorectal cancer: An excellent example of PHC at work is the KRAS mutation test, which will be made available in India in 2009. This test helps in direct treatment of patients afflicted with metastatic colorectal cancer. Recently, scientists have developed more targeted therapies for colorectal cancer that look at limiting the growth of cancerous cells. One such therapyis the Epidermal Growth Factor Receptor (EGFR) inhibitor (or anti-EGFR therapy), which prevents growth signals from entering the cells, thus stunting the growth of the tumour. The KRAS gene is a defining factor in looking at whether a patient with colorectal cancer can benefit from EGFR inhibitors. Patients with a mutated KRAS gene (35-45 per cent of metastatic colorectal cancer patients) are unlikely to respond to EGFR inhibitors. With the TheraScreen® K-RAS mutation test, doctors as well as patients will have a better understanding of treatment options to employ for achieving greater effectiveness.

Lung cancer: The TheraScreen® EGFR 29 test is designed for detecting 29 of the most common somatic mutations in the EGFR gene and also detects mutations not visible by sequencing. Recent studies in Non-Small Cell Lung Cancer (NSCLC) have shown that some patients carry somatic mutations in the EGFR gene. These mutations may correlate with responsiveness to the EGFR tyrosine kinase inhibitors, a targeted therapy for NSCLC.

Cardiac

N-terminal proBNP (NT-proBNP) is an ideal example of all aspects of PHC. It can be used to screen people at risk for Cardiovascular (CV) disease, and also in otherwise healthy people for early detection. For example, after a heart attack or after chemotherapy, it can diagnose Congestive Heart Failure (CHF) and help differentiate heart versus non-cardiac causes of shortness of breath. High levels of NT-proBNP also show a worse outcome, indicating that these patients must be treated more aggressively. It can also be used to monitor and guide treatment – the reduction in NT-proBNP is useful to optimise treatment in selected patients.

Virology

Human Immunodeficiency Virus (HIV): The way HIV patients regularly test their viral load is an example of PHC. Patients can get their viral load tested (along with a CD4 cell count) when first diagnosed with HIV – this acts as baseline. They are then tested again 2-6 weeks after the treatment is initiated to evaluate the efficacy of the therapy. Subsequent tests are carried out every three to four months to monitor long-term therapy to ensure that the patient has not developed resistance to the drug.

Hepatitis C Virus (HCV): Hepatitis is a viral infection that can go undetected in the body for years. If left untreated, it can lead to cirrhosis, liver failure and cancer. Tests that diagnose and monitor the virus in blood and treatment with Roche’s drug – Pegasys – have helped many people infected with it. However, not all patients respond equally to this treatment. A Roche Hepatitis C viral load test measures early response to therapy with drugs such as Pegasys, while another test that identifies the HCV subtype provides information to help determine the correct duration of treatment with such medicines.

A shorter treatment duration with Pegasys/Copegus will provide patients with the full benefits of therapy while reducing unnecessary drug exposure. The four-month treatment course will be for patients who are infected with particular strains of chronic hepatitis C (genotype 2 or 3), have low virus levels before starting treatment and who show a rapid virological response by clearing the virus from the blood within the first 4 weeks of treatment. This is a new treatment concept in hepatitis C, which seeks to customise regimens for patients based on how well they respond to treatment. It is enabled by using Roche’s highly sensitive, real-time Polymerase Chain Reaction (PCR) diagnostic tests (the automated COBAS AmpliPrep/COBAS TaqMan HCV Test), which accurately measure the levels of virus in the patient’s blood.

Metabolism

Diabetes: Roche Diagnostics provides blood glucose tests, insulin pumps and a whole series of services to tailor insulin treatment to patients’ needs.

Osteoporosis: A broad range of tests are made available by Roche Diagnostics to assess bone integrity and monitor the effects of anti-resorptive therapy with drugs such as Bonviva.

Drug metabolism

The AmpliChip CYP450 Test analyses variations in two genes that play a major role in the metabolism of many widely prescribed drugs. This is the world’s first commercial pharmacogenetic product for predicting individual drug response that implements gene chip technology.

Transplantation

CellCept is an immunosuppressant manufactured by Roche to prevent the body from rejecting a kidney, liver or heart transplant. The key metabolite in CellCept is Mycophenolic Acid (MPA). An immunochemistry-based test measuring MPA guides optimal patient dosing. This enables doctors to accurately tailor CellCept dosages and safely lower the dosages of more toxic agents, thus further improving the outcome for patients.