Healthcare authorities across the G7markets (France, Germany, Italy, Spain, UK, USA and the Japan) have been busy implementing oncology regulatory, pricing, and reimbursement reforms from 2008.
Driven by their high budget deficits post-recession, governments through their austerity packages want a significant drug price cuts to reduce overall oncology expenditures. Pharmaceutical companies need to be mindful of the new market access and reimbursement requirements. New drugs and indications in oncology need to prove their cost effectiveness against marketed comparators in Germany and France. However, several countries are working on improving breast cancer patient access to certain innovative and expensive drugs.
The most widely used drugs for breast cancer are hormonal therapies and chemotherapies – two types of therapies with long-established histories in breast cancer treatments. Hoffmann Krueger reports the countries oncology reimbursement particularities.
Drugs treatments for breast cancer are generally covered by private insurance and/or Medicare in US. Under private insurance, reimbursement varies according to the index plan as well as formulary tier placement within the index plan. In some cases, expensive treatment may not be reimbursed, such as trastuzumab and bevacizumab.
Office-based oncologists still receive a fee-for-service for administering intravenous therapies. In contrast, prescription of oral chemotherapy garners no specific fee-for-service. Medicare reimbursement policies are shaped by the United States Pharmacopeia’s (USP) Guidelines. These guidelines indicate that health plans must cover “all or substantially all” drugs in six classes, including antineoplastics.
Cancer patients in France do not have to worry about payments for essential drugs. In general, oncology drugs are fully reimbursed because they treat life-threatening diseases. Initiatives taken by the French government including the creation of the Institut National du Cancer (INCa; National Cancer Institute) and the Plan Hôpital (Hospital Plan) have improved care to cancer patients.
To control spending on drugs that qualify for supplementary reimbursement, ceiling prices are determined either through negotiations between the manufacturers and the Comité Economique des Produits de Santé (CEPS; Economic Committee for Health Care Products)
Manufacturers are also subject to price/volume constraints, they have to reduce their prices if sales volume is judged to have grown excessively. High-priced new drugs can be added to this list as soon as they receive marketing authorization in France.
After 12 months on the market, a drug is either approved to remain on this list, in which case it becomes subject to a ceiling price, or it is removed from the supplementary reimbursement list and covered by the relevant disease-associated tariff payable to the hospital.
To encourage hospital pharmacies to negotiate manufacturer discounts on these medicines, hospitals are permitted to keep a proportion of any price difference they secure between the ceiling price and their actual purchase price. When evaluating agents for reimbursement, France’s Transparency Commission considers the Service Medical Rendu (SMR; therapeutic benefit) and melioration du Service Medical Rendu (ASMR; improvement in therapeutic benefit) of the agents and target population characteristics. Because the SMR and ASMR ratings are considered important for drugs as bevacizumab, docetaxel, paclitaxel, and capecitabine and because breast cancer is a serious disorder, the treatments are fully reimbursed.
Unlike in many other European markets, cancer patients in Germany are frequently treated by office based physicians. Office-based physicians are currently subject to Richtgrößen—indicative prescribing amounts those determine the maximum expenditure on medicines per patient per quarter. Clinicians who exceed these amounts by more than 25% face the prospect of heavy fines. Some expensive therapies are excluded from indicative prescribing amounts.
In Germany, cancer patients frequently have out-of-pocket costs that are high by European standards. In line with the German Social Security Code’s goal of maintaining cost-effectiveness in medical treatments, German law dissuades off-label prescribing of any medications, levying a fine on the prescribing physician
In UK all citizens are eligible for prescription drug reimbursement from the National Health Service (NHS) for licensed therapies. Patients pay a low, flat prescribing fee per prescription; seniors and cancer patients are exempt from copayments.
The NICE (National Institute for Health and Clinical Excellence – NICE) have an important role in evaluation of the cost-benefit balance for new drugs and indications treatments. If NICE issues a negative opinion, most Primary Care Trusts (PCTs) exclude the drug from their formularies, obligating patients to either pay out-of-pocket treatment
Many NICE decisions regarding expensive treatments have been reimbursement controversies (e.g., trastuzumab in early-stage HER2-positive; trastuzumab beyond progression; lapatinib in combination with capecitabine as a second-line treatment).
British oncology experts notice that NICE recommendations do not result in automatic reimbursement of expensive treatments. For this reason, variation among PCTs in formulary coverage, yields an inequitable environment in which certain patients, depending on geographic location, can afford vital medications while others cannot. Thought leaders interviewed also indicate that because cost is such a concern, oncologists often choose the least-expensive drug within a desired class (e.g., generic paclitaxel over branded docetaxel (Taxotere)).
Oncologists in Italy indicate that any drug may be prescribed forbreast cancer if it is approved by the Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency); however, cost-containment measures have created some regional differences in prescribing. Some oncologists believe strongly that cost is a big problem, some others say they do not feel particularly constrained by the guidelines within which they are required to prescribe.
The Prontuario Farmaceutico Nazionale (PFN: National Pharmaceutical Formulary) classifies the reimbursement status of available therapies. Current metastatic breast cancer therapies are awarded class status H, indicating that full reimbursement is provided only in the hospital setting. The administration of class H requires specialist supervision.
In Spain the Sistema Nacional de Salud (SNS; National Health System) covers the full cost of medications or requires a nonrefundable patient copayment for part of the cost. oncologist note that no significant reimbursement obstacles hinder the prescribing of most breast cancer therapies. However, labeling and treatment location may affect whether a particular drug will be used because it may not be completely reimbursed.
The exception in breast cancer is trastuzumab, which was being prescribed for early-stage prior to the European Medicines Agency’s approval for that indication. Additionally, it is unlikely that expensive agents such as bevacizumab will be prescribed by hospital-based physicians because hospitals closely watch their annual pharmacy budgets.
Although lack of access to international gold-standard cancer therapies has long been one of the main deficiencies of the Japanese oncology system for many tumor types, several of the key chemotherapeutics used to treat breast cancer have been available in Japan within one to three years of their launch in other major countries. Biologics (such as trastuzumab) generally reach the market in Japan two to three years after their launch in other major pharmaceutical markets.
In an effort to accelerate the launch of important new drugs in Japan, in January 2005, the Ministry of Health, Labor, and Welfare (MHLW) established an expert panel called the Mishoninyaku Shiyo Mondai Kentokaigi (Study Council on the Use of Unapproved Drugs). Once a drug is considered to have significant potential and is recommended by the study council to the MHLW, the drug manufacturer is asked by the MHLW either to begin clinical trials or to conduct supplementary trials that would allow wider access to the agent before it is formally approved. Off-label prescribing is reportedly uncommon because it presents reimbursement problems, and the patient is forced to pay the whole cost of treatment.
The Japanese KOL reports that regulatory approval is the most critical variable in prescribing drugs in Japan, followed by efficacy; cost is generally not considered a defining variable. Once approved, drugs in Japan must undergo a rigorous pricing process and then possibly face the prospect of biennial price cuts. Although it is not the case with all chemotherapeutics, the Japanese prices of some breast cancer therapies (e.g., docetaxel) are the lowest of any of the major markets we cover— the result of several mandatory government price cuts. However, the prices of generic therapies are much higher in Japan than they are in the other major markets.
The emergence of novel targeted agents such as lapatinib and bevacizumab has resulted in growing disparity in access to expensive treatments in the G7 markets. As previously mentioned, MAbs are usually subject to intense scrutiny by payers. Even when they receive regulatory approval, not all MAbs are placed on drug formularies and reimbursement lists.
Reimbursement can be a particular problem for patients with late-stage breast cancer because premium-priced agents must show clinically relevant and cost-effective benefit in these patients.
Compared with physicians in the UK and the rest of Europe, physicians in the United States experience significantly fewer reimbursement restrictions. As we discussed, bevacizumab was conditionally approved in 2008 under the FDA’s fast-track development program to treat metastatic HER2-negative breast cancer. Most oncologists in the United States disagree with ODAC’s recommendation and tell us that they will continue to prescribe bevacizumab to their patients for as long as it continues to be reimbursed.
Hoffmann Krueger Oncology Excellence