Specialist Forum chatted to Vivian Frittelli, CEO of Generic and Biosimilar Medicines of Southern Africa about the growing generic market in South Africa and its implications.
Between 70% and 90% of all pharmacy‐filled prescriptions in the Netherlands, United States and England are filled with generic drugs. In South Africa, the generic medicines market share of the private market is 66% in terms of volume. When one considers that approximately 80% of medicines bought by the State are generic medicines, the overall rate of generic usage in 75%, according to IQVIA, an American multinational company involved in health information technologies and clinical research.
Frittelli explains that although the quantity of generics in the private market has a share of 66%, the value of this is 43%, which means that roughly 57% is spent on the originators 34% value share. Mediscor, a pharmacy benefit company, says in their latest 2017 review, that where a generic equivalent was available, it was used in 77.8% of cases.
This favourable growth in the utilisation of generic drugs (from 35% in 2007 to 77.8% in 2017), might be due to medical schemes’ enforced formularies, says Frittelli, which contributed to increased prescribing among general practitioners (GPs). Mediscor estimates that GPs have a generic initiation rate of 74%.
“Anecdotally, specialists would tend to stick to originator drugs, not through ignorance of the efficacy of generic medicines, but probably because they were first introduced to the original medicine when it was at the innovative stage, and they have remained comfortable with the drug.”
In an interview last year with Dr Jacques Snyman, CEO of Medical Specialist Holdings, and a clinical pharmacologist, he said one of the major stumbling blocks in growing the generics market in South Africa, is even more ‘aggressive marketing’ by some pharmaceutical companies.
Asked what his view was on the matter, Frittelli says although the term ‘aggressive marketing’ is used often, it is not clear what exactly it means. “If it means that originator companies have more resources to apply to the promotion of their drugs, this would be accurate. Generic drugs being less expensive do not have the same monetary resources for marketing.”
What does the approval process for generics entail before they can come to market?
The approval process for medicines in South Africa is the same for original and generic medicines. The applicant compiles a ‘dossier’ according to a template dictated by the regulatory authority. This dossier is a ‘curriculum vitae’ of the drug from inception to manufacturing and therapeutic results. The dossier is evaluated by various committees/investigators within the regulator and a positive or negative outcome arrived at.
The major difference in the registration of an originator and a generic medicine is that the generic applicant once they have proven biopharmaceutical equivalence, does not have to undergo the three phases of clinical trials which is required of an innovator product. A clinical trial involving a small sample of only 200 patients could easily cost in the region of $40 million.
Also, most double-blinded trials involve a control group that receives a placebo drug, it would be unethical to subject patients to this once a known cure/benefit is achieved.
How long does it take to get a generic drug on the market?
Although generic manufacturers do not need to repeat safety and efficacy studies as in the case of originator drugs, it still takes on average four to five years to register a generic drug in South Africa. This is mainly due to a lack of resources within the regulator.
The new regulator, known as the South African Health Products Regulatory Authority, which succeeded the Medicines Control Council about a year ago, acknowledged that there are about 15 000 medicines in the backlog awaiting registration approval. Most of these are generic medicines.
The registration of generic drugs is an independent process and drugs approved by the American Food and Drug Administration, has no bearing on what is or will be available in South Africa.
What are some of the advantages/benefits of using generics?
When an ‘originator’ company innovates a new molecule/medicine, the company applies for a patent, which if granted is valid for 20 years, explains Frittelli. We have a system which virtually rubberstamps pharmaceutical patents as granted ‘provided the form is filled in correctly’, he adds.
While the medicine is patent protected, no one can copy the product. The innovator therefore enjoys exclusivity of sales for the duration of the patent. The patent holder also sets the starting price of the medicine.
Originator medications are typically 30%–60% more expensive than their generic counterparts. Only after the patent expires, are generic manufacturers allowed to copy the medicine. “This brings competition into the market place including price competition, when more than one company launches the drug.
Often this causes the originator to reduce price. So, the patient is given more choice and there is a wider availability of the drug. If the originator cannot supply enough to the market, there are other options.” The Association for Accessible Medicines released its 2018 Generic Access and Savings Report in the United States recently.
The report was compiled using the independent findings of IQVIA about generic drug savings. Key findings include:
- Generic medicines generated a total of R37tn in savings
- Average patient copayment for a generic prescription is R86
- 93% of generic prescriptions are filled at R283 or less
- Patients fail to fill their prescriptions for brand name drugs at a rate 2-3 times higher than for generics
- The most savings from generic drugs were found in mental health (R600bn), cholesterol (R481bn) and hypertension (R439bn) treatments.
What are the most commonly used generic drugs used in South Africa?
The most used generic drugs are antiretrovirals (ARVs). Currently, close on four million South Africans infected with HIV depend on the state for their ARV treatment, concluded Frittelli. The use of generic ARVs have saved the tax payers of South Africa billions of rands.
What are the views of patients?
A review article by Weissenfield et al evaluated patient adherence and attitudes toward generic substitution found that about 66% of patients are generally in favour of generic substitution. However, among patients treated for psychological diseases, who had had their medication substituted to a generic version, 34% experienced additional adverse events because of their poor perceptions of the generic drug.
This is termed the ‘nocebo’ effect. A 2011 Finnish study by Heikkila et al found that 80.9% of the participants in their study believed that generic medications were effective and most (84.9%) thought generic substitution did not pose a risk to safety.
So, it seems as though patients have no problem with substitution, but what are the views of GPs and pharmacists?
Shrank et al (2011) explored physician perceptions about generic drugs. They found that 23% and 50% of physicians respectively had negative perceptions about the efficacy of generic drugs and the quality. More than 25% indicated that they do not prefer to use generics as first-line medications for themselves or for their families.
In addition, the researchers found that physicians over the age of 55 years were 3.3 times more likely to report negative perceptions about generic quality, 5.8 times more likely to report that they would not use generics themselves, and 7.5 times more likely to state that they would not recommend generics for family members. Physicians reported that pharmaceutical company representatives are the most common (75%) source of information about market entry of a generic drug.
Dunne et al (2014) conducted interview-based surveys of GPs and pharmacists in Ireland. Their results show 91% of GPs and 97% of pharmacists strongly believed that generics and originator drugs were of similar quality. GPs, however, were slightly less supportive of generic equivalence.
Furthermore, significantly more GPs than pharmacists believed they do not work as well as innovative drugs (11.8% vs. 2.3%). In addition, 94% of GPs and 88.6% of pharmacists had received patient complaints about poorer efficacy and/or increased side-effects with generics. Experts agreed that gaps in healthcare providers and patients’ knowledge about the safety, efficacy and quality of generics should be addressed.