Specialist drugs: cost-effectiveness analysis. Ed

Huge figures compared to traditional medicines, which raise questions of accessibility and discrimination

The high costs of Sovaldi, Gilead's anti-hepatitis C, technical name sofosbuvir, which in the USA amount to 80 thousand dollars for 12 weeks of treatment, are sparking economic and ethical controversies and debates in the world. And if anyone wonders why the fuss, here is the answer published in Health Affairs by James Chambersdella Tufts University di Boston, Massachusetts: i farmaci specialistici stanno per invadere il mercato e il gioco in questo caso vale la candela. Si tratta di farmaci che nel 2013 erano meno dell’1% delle prescrizioni, ma circa un quarto della spesa farmaceutica, proporzione che nel 2016 potrebbe aumentare fino al 63%, in base alle stime di Express Scripts. E mentre Gilead assicura prezzi più bassi nei Paesi in via di sviluppo, c’è chi afferma che i nuovi farmaci dovrebbero costare centinaia di dollari, non decine di migliaia. Un altro esempio è il simeprevir della Johnson & Johnson: costa circa 66mila dollari, e se combinato a Sovaldi, come talvolta accade, porta la cura antiepatite a poco meno di 150 mila dollari, circa 100 mila euro, per un trimestre di cura. Cifre enormi rispetto alle medicine tradizionali, che sollevano questioni di accessibilità e discriminazione. Così Chambers ha confrontato nel 1999-2011 nuovi e vecchi farmaci per costi e guadagno di salute espresso in Qaly, un parametro di valutazione economica degli interventi sanitari. I risultati? Rispetto alle consuete medicine, quelle more recent increase the Qaly from 0.002 to 0.183 but also the additional costs: 12,238 against 784 dollars. Chambers concludes: "Specialist medicines do have higher costs than traditional ones, but they also tend to confer greater benefits and, therefore, can still offer good value for money". And in a commentary editorial, Alan Weil, director of Health Affairs, says: “Chambers and colleagues conclude that, overall, specialty drugs are not only comparable in cost-effectiveness to traditional drugs, but sometimes even greater. This suggests that their development and use is a benefit to society, but sadly fails to answer a question: who has to pay, and how much, to receive that benefit?

Health Aff (Millwood). 2014 Oct 1;33(10):1751-60 . doi: 10.1377/hlthaff.2014.0574
Health Aff (Millwood). 2014 Oct 1;33(10):1710. doi: 10.1377/hlthaff.2014.1091

Ed.: Here's the flip side of the mass Whistleblower firings: 13,400 from 2007 to today. Since 2006 pharmaceutical companies have decided to change strategy. That is, abandoning in practice the so-called primary care (drugs for basic medicine) deemed no longer profitable due to the advent of generics and the consequent transfer of most of the prescriptions from doctors to pharmacists and/or administrators of the Health Service and aiming on biotechnological, oncological and specialist drugs. This strategy would have allowed enormous added values and reduced fixed costs (whistleblowers are so called by pharmaceutical companies).

The result in Italy is the dismissal of at least one third of Scientific Representatives operating in basic medicine, enormous costs for the various national health services and, last but not least, the lack of new medicines for basic medicine, emblematic the case of antibiotics.

If the various national, health and trade union authorities are not interested in the Whistleblowers, they should be interested, and very much, in the other aspects of the matter. Sometimes we look at the epiphenomena, but nothing is resolved, on the contrary, everything is silent.

This “Big Pharma” operation happened in conjunction with the economic/financial crisis so all these layoffs could be masked by the general crisis. And yes, there is the crisis … .

However, the pharmaceutical sector has never had a crisis (e not only in Italy and is expected a annual increase of 5% until at least 2020), indeed it has always increased its turnover and even increased its exports in this same period of the 64% (see ISTAT data).

Some would say that there are strong powers (and here they are really strong!).

Related news: Pharmaceutical. Which criterion to define the reimbursement price of drugs?

Related news: AIFA. The pharmaceutical challenges of the ultra-globalized world

Related news: Le Monde. «The faut établir un lien entre le prix d'un médicament et son lieu de production»

Eugenio Aringhieri, Farmindustria: "Biotech is a great opportunity for Italy"

Interview with the president of the biotech group of Farmindustria: "Research is carried out by competent people who also manage to think outside the box, in which luckily we continue to invest"

In the world, 350 million patients are treated with biotech drugs, practically a fifth of the total number of medicines on the market. Pharmaceuticals alone represent 92% of Italian biotech turnover with volumes of over 5 billion euros a year. Eugenio Aringhieri, 54-year-old president of the Farmindustria biotech group, as well as CEO of the biopharmaceutical company Dompé, sees a great opportunity for Italy in the sector.

What does biotech represent for the Italian economy?

“A great opportunity, both industrial and strategic. THE Western countries can no longer compete in low-tech sectors. Conversely, competitiveness is greater in hi-tech markets, where Italy can play its game. We understood it immediately and we are doing well: our biotech companies are focusing on scientific research and the specialization of human resources, with an increase in investments of 2.4% compared to last year”.

And how is this trust justified?

“Biotech-based treatments are often the only possible cure for rare diseases, but above all they are a response in areas of medicine that still have a high demand for health, such as oncology, neurology and infectious disease. In Italy there are already 110 biotech drugs on the market, but there is a strong growth trend because another 403 drugs are under development, and 62% of these is already in an advanced stage of human trials. And if today about half of the drugs under development are biotech, in 2025 it will be 75%".

An opportunity also for the world of research then?

“Especially for young people, because research is done by competent people who also manage to think outside the box, in which luckily we continue to invest”.

Is the case of Eos, the Milanese startup sold last year to Clovis Oncology for 400 million dollars, replicable?

“Yes, because in this sector the critical success factor is not the size of a company, but the innovative results. There are already other projects at an advanced stage and we can gain positions in the global market”.

How can we improve?

“There is still a lot to do. In Italy we have a delay in placing new products on the market of 300 days compared to Germany and the United Kingdom. If we consider that the remedies are produced for serious pathologies or for cancer patients, we often don't even have a year of time”.

Is there a culture favorable to biotech in Italy?

“I'll cite an example: Francesca Damadei, who in July, at the age of just 19, represented Italy at the London International Youth Science Forum to promote the role of biotech. For young people, scientific subjects are important: according to Istat, the loss of employment was less for graduates in scientific subjects than for engineering and medicine”.