Is Prioritization of the Hepatitis C Cure Ethical?

A study published by the European Review for Medical and Pharmacological Sciences explores the possible options to make treatment of hepatitis C virus (HCV) sustainable and ethical.

Health systems in all countries have a problem of distributive justice when it comes to high-cost HCV medication. Health systems should guarantee individual rights, but also grant equal access to resources and keep the distribution system sustainable, according to the article.

A majority of countries have implemented a policy to stratify the patients for treatment prioritization. According to the article, this means interferon-free direct acting antiviral (DAA) treatment will only be given to patients with advanced fibrosis or cirrhosis, while patients in lesser stages of the disease will not receive the treatment.

Economical Impact and Access to Care

According to the article, the cost of HCV drugs has created “sticker shock” in a majority of countries.

Costs keep increasing due to IFN-free combination therapies with 2 or more DAAs for most patients. Longer treatment periods for patients with cirrhosis also increases costs.

Combining evaluations of real-life efficacy with pharmaco-economical analyses and Health Technology Assessment (HTA) reports will avoid economic speculation and medical tourism to countries that offer these drugs at lower costs.

Though costs are high, recent studies found that DAA-based treatments for HCV genotype 1 are cost-effective. Discounting efforts also state that the drugs will become even more affordable.

The study states that cost-effectiveness and costs are not equivalent, since cost-effective does not necessarily mean financial sustainability in the short-term. Since treatments would be applied to patients over a brief period, there could possibly be a budgetary strain.

Due to cost and access issues, many patients are being denied treatment. The study authors suggest using policies for mixed use of IFN-containing and IFN-free regimens to reduce costs.

The cost seems to be the most significant reason HCV has not been eradicated. Conquering this hurdle will require healthcare providers, drug manufacturers, local and national government, and other stakeholders to work together to reduce costs.

Manufacturers specifically need to have more ethical profit margins, according to the study.

Distributive Justice in Medicine

As individuals, we wish to have the biggest benefit in terms of health for ourselves, but as a society, there needs to be a balance between the best possible results for individuals and the needs of the society.

Study authors believe individual rights should be guaranteed, including the right to health, therefore equal access to resources needs to be granted. Due to these reasons, it is necessary and urgent to ethically assess the access and prioritization of new DAA treatments.

According to the study, healthcare ethics can be divided into 3 categories:

• Distributive justice: fair distribution of sparse resources
• Rights-based justice: respect for people’s rights
• Legal justice: respect for morally acceptable laws

Though macro-allocative decisions or policy decisions can affect distributive justice, this study focuses on micro-allocative decisions or decisions that affect singular patients.

Individualistic Libertarianism, Social Utilitarianism and Egalitarianism

Different ethical models can mean that justice in the healthcare system can change depending on the model adopted.

For example, individualistic libertarianism places a higher value on individual freedom than on social benefit. It aims for the maximum freedom for individuals and views justice as not damaging others.

On a micro-allocative level, the selection of the patient and the prioritization for treatment is dependent on individual choice and the ability to pay. Utilitarianism is based on utility and approves actions that increase happiness and disapproves every action that goes against that.

On a micro-allocative level, patients who are expected to return to productivity would be preferred in the selection. Lastly, egalitarianism privileges social benefit over individual freedom, which requires reducing individual choice in order to favor equality for all.

On a micro-allocative level, it can guarantee equal access to a cure and provide the same opportunities to everyone.

Assessing Individual Health Needs

Since the progression differs for each individual, researchers state that identifying, quantifying, and then scaling the health needs of patients is important to track the progression of the disease.

Patients with clinically evident cirrhosis or other serious comorbidities would be the group who would benefit the most from new DAA drugs. Patients with advanced fibrosis or cirrhosis showing no symptoms would be included in the next group.

According to the study, using multivariate risk modeling to assess different variables that affect SVR could result in more detailed treatment comparisons.

HCV symptoms that may lower the quality of life during the wait period for treatment should also be taken into account.

Any possible health benefit of waiting for IFN-free therapy rather than immediate IFN-containing regimen is said to be lost if patients wait for the new therapy for over 3 years.

Screening

Stratifying early stage patients would be quite difficult, so the possibility of accelerated progression and a new DAA make an argument that treatment should be offered to everyone. However, overtreatment could raise costs even further.

Approximately 90% of HCV-positive patients are unaware of their status worldwide, according to the study. Identifying and testing at-risk populations is a critical step towards eradicating HCV.

In addition, certain studies state that birth-cohort screening policies are cost-effective and others state that treating younger groups could potentially maximize medical costs.

No affordable and realistic strategy has been developed to implement a population-aide screening.

Though more screening would identify more HCV-infected patients, researchers stress that wrong screening results could jeopardize relationships, employment, and insurance status.

Ideally, infected patients found through screening should have access to affordable treatment, regardless of the stage of their liver disease.

A balance between individual rights and societal benefit can be reached by taking into account factors such as the history of the disease, its prevalence, ability to predict the course and availability of a cure, and the willingness of patients to be screened and cured if needed.

Financial, organizational, industrial, and political constraints should be held as primary decision cofactors in regulating ease of access to care.

The decision process will need further knowledge of the long term effects of only administering the cure to advanced stage patients, the study concluded.