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    a. Has all of the relevant evidence been taken into account?

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1 Recommendations

1.1

Palopegteriparatide should not be used to treat chronic hypoparathyroidism in adults.

1.2

This recommendation is not intended to affect treatment with palopegteriparatide that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

What this means in practice

These are NICE's draft recommendations. If these recommendations become final, palopegteriparatide would not be required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because there is not enough evidence to determine whether palopegteriparatide is value for money in this population.

Why the committee made these recommendations

Usual treatment for chronic hypoparathyroidism is calcium and active vitamin D supplements. Some people also have thiazide diuretics.

For this evaluation, the company asked for palopegteriparatide to be considered only for people with chronic hypoparathyroidism that is not adequately controlled with usual treatment. This does not include everyone who it is licensed for. 

Results from a clinical trial comparing palopegteriparatide plus usual treatment with placebo plus usual treatment are uncertain. This is because the trial design may not allow a fair comparison, for reasons including:

  • usual treatment in the trial may not be the same as usual treatment in the NHS

  • the way that the trial measured how well the treatments work may not show whether palopegteriparatide plus usual treatment works better than usual treatment alone.

The cost-effectiveness estimates are substantially above the range that NICE considers an acceptable use of NHS resources. They are also highly uncertain because the evidence used in the economic model is uncertain.

Because palopegteriparatide is not cost effective in this population, the company has now asked for it to be considered only for people:

  • with chronic hypoparathyroidism that is not adequately controlled with usual treatment, and

  • who have had at least 2 hospital admissions in the last year.

The company suggests that palopegteriparatide is more likely to be cost effective for this group. Further analyses are needed, so palopegteriparatide should not be used.