by Helen Collis
LONDON, Nov 24 (APM) - Sweden’s health technology assessment body TLV has backed the early introduction of drugs based on limited data, but said industry needs to accept flexible pricing that may see prices go up and down based on emerging study results.
Speaking at the European Medicines Agency/TOPRA regulators meeting, Wing Cheng, coordinator of scientific advice at TLV, said Sweden had already introduced a similar pricing model under its own early market entry scheme.
He said this flexible pricing model also needed to be followed for drugs considered for early access under Europe’s adaptive licensing scheme, where new therapies can be approved in small, targeted populations from positive Phase II data.
He told the meeting on Thursday: “If you don’t have a proper follow up and results are not shown, then you need to be open to flexible prices - higher and lower - and it’s a challenging topic to discuss with different stakeholders.”
He underlined that under this pricing model, drug prices needed to initially be based on existing data at the time of market entry.
Companies and payers need to “develop pricing in the early phase of a drug’s (development), even if data is limited,” he said.
The price may go up as more positive data is compiled and would likely go down later in its life cycle as better innovative medicines come onto the market.
“We need to develop medicine pricing models so that each time there is a new event (from study results to side effects or competition) we need to assess the price,” he said.
He added that due to tight budgets, new drugs were not used as often as they "should be". He said: “To enable cost control during the life cycle of a drug, cost-effectiveness needs to be monitored throughout the life cycle of a drug.”
Cheng said in Sweden, the health technology assessment body has just completed a pilot study on getting drugs approved via the EMA's adaptive licensing system into use.
“The goal is to establish a national plan to develop adaptive licensing to be introduced and adjusted to a Swedish setting … to align adaptive licensing with the managed entry system in Sweden.”
He said Sweden’s market entry system was not so different from the European Medicines Agency’s adaptive licensing model. Under Sweden’s system, the TLV speaks weekly with regional healthcare authorities, known as county councils, who control drugs spending in their locality.
The study concluded that the TLV “needs to be working more actively with county councils who are providing the healthcare - they are important payers.
“That’s what we are doing at the TLV, by involving county councils … They are assisting the TLV in the assessment of new drugs.”
Therefore, few changes would be needed in Sweden to accommodate for the EMA’s early access scheme, he said.
“The conclusion (of the pilot) is that a national strategy can be established and there’s no new processes needed. The process of adaptive licensing sits very well with our national process of managed introduction of new medicines.”
He cautioned however, that they would “need additional resources,” and stakeholders needed “to have more understanding of price flexibility”.
The conference heard that Sweden was advanced in its preparation for adaptive licensing compared with other EU member states. “We are willing to discuss potential candidates,” Cheng said.
The EMA’s adaptive licensing programme is being piloted, and the agency has so far accepted six applications to enter into the second, in-depth discussions phase.
The agency last week urged industry to hurry to enter the pilot, which will close to new applicants in February. (APMMA 40523)
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