NCCN Guidelines for Myeloproliferative Neoplasms V.1.

2022 – Email Vote on 12/07/21

Guideline Page Institution Vote

Panel Discussion/References
and Request YES NO ABSTAIN ABSENT
MF-2 Based on the review of the data in the noted 17 1 2 11
Internal request: reference, the panel consensus was that the use of
fedratinib is supported by high-level evidence and the
Comment to review the data for fedratinib, in the category was changed from a category 2B to a
setting of higher-risk MF with platelets ≥50 X 109/L and category 1 recommendation.
not a transplant candidate. Its use in the frontline
setting is very similar to that of ruxolitinib. Reference:
Safety and efficacy of fedratinib in patients with
primary or secondary myelofibrosis: A randomized
clinical trial.
MF-2 Based on the review of the data in the noted 20 0 0 11
Internal request: reference(s), the panel consensus was that the use
of ruxolitinib is supported by high-level evidence and
Comment to review the data for ruxolitinib, in the the category was changed from a category 2A to a
setting of higher-risk MF with platelets ≥50 X 109/L and category 1 recommendation.
not a transplant candidate. Does the data support a
category 1 recommendation? References:
• A double-blind, placebo-controlled trial of
ruxolitinib for myelofibrosis.
• JAK inhibition with ruxolitinib versus best
available therapy for myelofibrosis.
PV-1 Based on a review of the data and discussion, the 16 3 1 11
External request: panel consensus supported the inclusion of
ropeginterferon alfa-2b-njft as an option for the
Submission from PharmaEssentia (11/14/21) to treatment of low-risk PV. This is a category 2B, other
consider the addition of ropeginterferon alfa-2b-njft for recommended regimen.
the treatment of low-risk polycythemia vera (PV) under
aspirin and phlebotomy as preferred, category 1 The panel consensus did not support a category 1 8 10 2 11
recommendation. recommendation.

The panel consensus did not support a preferred n/a n/a n/a n/a
regimen recommendation.

Reference:
Ropeginterferon alfa-2b versus phlebotomy in low-
risk patients with polycythemia vera (Low-PV study):
a multicentre, randomized phase 2 trial
NCCN Guidelines for Myeloproliferative Neoplasms V.1.2022 – Email Vote on 12/07/21

PV-2 Based on a review of the data and discussion, the 18 1 1 11

External request:
Submission from PharmaEssentia (11/14/21) to
consider the addition of ropeginterferon alfa-2b-njft for
the first-line treatment of high-risk PV as a preferred,
category 1 recommendation.
panel consensus supported the inclusion of
ropeginterferon alfa-2b-njft as an initial cytoreductive
therapy option for the treatment of high-risk PV. This
is a category 2A, other recommended regimen.
The panel consensus did not support a category 1 11 7 2 11
recommendation.

The panel consensus did not support a preferred n/a n/a n/a n/a
regimen recommendation.

PV-2
External request:
Submission from PharmaEssentia (11/14/21) to
consider the addition of ropeginterferon alfa-2b-njft for
the second-line treatment of high-risk PV as a
preferred, category 1 recommendation.
Reference:
A randomized, non-inferiority, phase 3 trial and its
extension study.
Based on a review of the data and discussion, the 19 0 1 11
panel consensus supported the inclusion of
ropeginterferon alfa-2b-njft, if not previously used as
a subsequent-line treatment option for
inadequate response or loss of response for high-risk
PV. This is a category 2A, other recommended
regimen.

The panel consensus did not support a category 1 6 11 3 11

recommendation.

The panel consensus did not support a preferred n/a n/a n/a n/a
regimen recommendation.
NCCN Guidelines for Myeloproliferative Neoplasms V.1.2022 – Email Vote on 12/07/21

PV-2 Based on a review of the data and discussion, the 18 0 2 11

Internal request:
Do you agree with the addition of ropeginterferon alfa-
2b-njft, if not previously used as a subsequent-line
treatment option for inadequate response or loss of
response for low-risk PV.
panel consensus supported the inclusion of
ropeginterferon alfa-2b-njft, if not previously used as
a subsequent-line treatment option for
inadequate response or loss of response for low-risk
PV. This is a category 2A, other recommended
regimen.

The panel consensus did not support a category 1 6 12 2 11

recommendation.

The panel consensus did not support a preferred n/a n/a n/a n/a
regimen recommendation.
PV-2 The panel consensus supported the inclusion of 16 2 2 11
Internal request: ropeginterferon alfa-2b-njft for footnote “j”.

Do you agree with the addition of ropeginterferon alfa-

2b-njft for footnote “j”?
PV-2 Based on the review of the data in the noted 19 0 1 11
Internal request: reference(s), the panel consensus was that ruxolitinib
is supported by high-level evidence and the category
Do you agree that ruxolitinib should be a category 1 was changed from a category 2A to a category 1
recommendation for inadequate response or loss or recommendation for inadequate response or loss of
response for high-risk PV? responses for high-risk PV.

PV-2
Internal request:
Do you agree that busulfan (category 2B) under useful
in certain circumstances should be removed from the
algorithm, but included in the Discussion for high-risk
PV?
References:
• Ruxolitinib versus standard therapy for the
treatment of polycythemia vera.
• Ruxolitinib for the treatment of inadequately
controlled polycythaemia vera without
splenomegaly (RESPONSE-2): a
randomised, open-label, phase 3b study.
The panel consensus supported the removal of 17 2 1 11
busulfan (category 2B) under useful in certain
circumstances for high-risk PV.
NCCN Guidelines for Myeloproliferative Neoplasms V.1.2022 – Email Vote on 12/07/21

PV-2 The panel consensus supported the removal of 15 2 3 11

Internal request: busulfan (category 2B) under useful in certain
circumstances for low-risk PV.
Do you agree that busulfan (category 2B) under useful
in certain circumstances should be removed from the
algorithm, but included in the Discussion for low-risk
PV?
ET-4 The panel consensus supported the inclusion of 19 0 1 11
Internal request: “anagrelide” to the first bullet (Intolerance or
resistance to hydroxyurea or peginterferon alfa-2a or
Do you agree that “anagrelide” should be added to the anagrelide) for inadequate response or loss of
first bullet (Intolerance or resistance to hydroxyurea or response for high-risk essential thrombocythemia
peginterferon alfa-2a or anagrelide) for inadequate (ET).
response or loss of response for high-risk essential
thrombocythemia (ET)?
ET-4 The panel consensus supported the removal of 16 3 1 11
Internal request: busulfan under useful in certain circumstances for
essential thrombocythemia (ET)?
Do you agree that busulfan under useful in certain
circumstances should be removed from the algorithm,
but included in the Discussion for essential
thrombocythemia (ET)?