Medicines and costs

Why do some medicines cost so much but then others, such as some generics, cost so little? Elsabé Klinck educates us as to why this is so.

Types of medicines

Medicines are widely defined in the Medicines and Related Substances Act. This law defines a medicine as something that is used to diagnose, treat or prevent disease, or help with bodily functioning. 

Medicines include: 

• Complementary medicines, such as supplements and vitamins.
• Alternative medicines, such as naturopathy, homeopathy and Ayurvedic medicines, many of which have a long history of cultural or traditional use.
• Allopathic medicines, such as the medicines used in cancer treatment and what one normally would access behind a pharmacy counter or on a prescription.

Allopathic medicines

Within allopathic medicines, there are medicines that are made from chemical processes, and others that are made from naturally-occurring substances, such as cells that grow. This last category is called biological medicines. Copies of biological medicines are called biosimilars and copies of medicines that are made through chemical processes are called generics.

In oncology care, various medicines may sometimes have to be taken together. 

It is, however, important that patients ask their oncologists before taking any medicine not prescribed by their oncologist, even if that medicine is described as ‘natural’ or a ‘supplement’. The reason for this is that medicines may work against each other, and may comprise the patient’s treatment, or even cause severe negative effects.

Biosimilars vs. generics

Biosimilars are medicines that are copies of biological medicines. The biological medicine would be the medicine that was initially discovered, researched and approved by the medicines authority. It is, in that sense, akin to generic medicines that are also copies of the originator medicine. 

The main difference is that, whereas generics and originators are human-made molecules, biologics are naturally-occurring substances that are grown. Perhaps the most well-known of the biologics are vaccines and insulins. 

Biologics and biosimilars are often called large molecule treatments, whilst generics and their innovators are called small molecule treatments. Biologics and biosimilars could be 200 to a 1000 times larger! Because of its biological nature (i.e. living cells that grow), a biosimilar is similar, but never the same as the biologic. In contrast, the molecule in a generic medicine is exactly the same as the originator medicine. 

Stricter regulations for biosimilars

Both biologics, and their copies, biosimilars, are difficult to manufacture. Each manufacturer uses its own cell lines, and its own purification processes. The regulatory requirements for biosimilars are therefore much stricter than with generic medicines. 

Because of the complexity of the molecules, and the multi-step processes of manufacturing it, whilst keeping the key aspects of the medicine similar, it’s more difficult to replicate a biological medicine. 

Whereas generics don’t have to demonstrate this to the same extent, biosimilars require studies in humans to show that it’s not different to the biologic. The more the differences, the more requirements medicine authorities will place on the biosimilar.

A biosimilar must only have one indication (one use), and not necessarily all the indications or uses of the original biologic. This is important to keep in mind when discussing treatment options with the doctor. Namely whether the biosimilar is approved for a specific treatment required by the patient.

Why do medicines cost so much?

Because biosimilars and generics are copies of the initial medicine, and the amount of research and development required are less, these versions of the medicine are often cheaper than the medicine initially developed. As cancer care is some of the most expensive, biosimilars have the benefit of potentially bringing down the cost of treatment.

The costs of medicine discovery, development and clinical trials (i.e. testing the medicine for safety first, and later for efficacy, i.e. whether it works or not), are significant. Millions of US dollars are spent on medicine development, and clinical trials. The median cost of which have been studied as at US$19m, is but one percent of the total development costs,  the total costs being billions of US dollars. Part of the reason for this is that many molecules that may show promise, don’t even make it to the significant phase 3 clinical trial stage. 

This data has been disputed,  but the fact remains that significant investment is needed to make a product work in the pharmaceutical industry.

Switching of medicines

The Medicines Act currently only compels pharmacists (and doctors or practices administering medicines) to switch to a generic version of a product if it’s cheaper than the originator medicine. The law, however, does not provide for switching a biological medicine to a biosimilar of that biologic. This is because the biosimilar is not identical to the biological medicine and automatic switches can therefore not occur. 

Therefore, the informed consent process should include discussing the biological medicine and any biosimilars available with the patient. The costs of care must also be discussed, as part of the informed consent process.

With generic switches, patients must still be informed that their medicine is being switched. A patient can refuse such a switch, but may have to co-pay the difference in cost between the generic and the innovator. 

The importance of informed consent processes

Given the possibilities in treating oncology with medicines, and other treatment options, such as radiation, it’s important that patients talk to their oncologists about the care they would require and the implications thereof. 

All patients are entitled to know what their options are, what the benefits are (e.g. cure rates, or with how much one’s life may be extended), the negative effects of the care (e.g. bad side effects, or other negative implications, such as causing other conditions), and the implications (e.g. what it would take of a patient to remain on the treatment, what the impact would be on his/her life, and dignity). 

Costs must also be discussed. Cheaper treatments may be less effective, or older treatments may have more negative effects, and so all. The issue of costs must therefore be addressed within context, and with the specific patient’s circumstances in mind. Patients must also ask about alternatives and options, and be able to compare those options. 

In conclusion, patients are encouraged to ask questions about the value of a medicine, and the role of that medicine within the complexity of treatment with other medicines or treatment options. This includes not only the prices of the various therapies, but also the impact on the patient.

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